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Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement

Primary Purpose

Bilateral Vocal Cord Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SPIRION Laryngeal Pacemaker System Implantation and follow-up
Sponsored by
MED-EL Elektromedizinische Geräte GesmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Vocal Cord Paralysis focused on measuring Bilateral Vocal Fold Paralysis, BVFP, Bilateral Vocal Cord Paralysis, BVCP, Laryngeal Pacemaker, Electrical Stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

General information The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria: Patients recruited in the previous first-in-human (FIH) clinical investigation 2011CIP001 Patients with an open tracheostoma at the time of enrolment Inclusion Criteria: Between 18 and 75 years old at the time of enrolment (i.e., informed consent form (ICF) signed) Diagnosed with BVFP for a minimum of 6 months Patients who underwent at least one permanent glottal enlargement. If revision surgeries were performed, they should have been conducted on the same side of the original surgery With sufficient autonomous respiratory capacity to maintain their vital functions independent of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the tracheostomy is carried out during this clinical investigation, the Principal Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal Pacemaker would not put the patient in a life-threatening condition because of insufficient respiratory patency The PCA innervating the vocal fold that never underwent a permanent glottal enlargement responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an Endoscopic Cap Electrode (ECE50) test, or shows reinnervation in an laryngeal electromyography (LEMG) assessment Fluent in German. Exclusion Criteria: Lack of compliance with any inclusion criteria Pregnant or breast-feeding women Patients suffering from an ongoing or chronic laryngeal inflammation at the time of enrolment Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, central nervous system (CNS) pathologies, and/or systemic diseases Patients who underwent previous bilateral permanent surgical glottal enlargement Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework surgery) that would compromise the correct SPIRION Electrode placement and/or the intended functionality of the SPIRION Laryngeal Pacemaker The adductor laryngeal muscles on either or both sides underwent a botulinum toxin injection that is still effective at the time of surgery (i.e., the respective VF position is either in intermediate or lateral position) Patients who underwent thoracic surgeries that would compromise at least one of the following procedures: Correct placement of the SPIRION Electrode or SPIRION Implant Connection of the SPIRION Implant with the SPIRION Electrode Connection of the SPIRION Implant with the external SPIRION Processor Patients wearing an active implantable medical device at the time of enrolment Patients with a clinical history that would suggest a high probability that they would need an MRI Patients diagnosed with a malignant disease in the head and neck region Patients diagnosed with chronic airway infections or obstructions, or severe respiratory diseases (e.g., chronic obstructive pulmonary disease (COPD) grade II or higher) Patients who underwent external beam radiation therapy in the surgical area Patients diagnosed with a serious coagulation disorder requiring an uninterruptable use of anticoagulants Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct contact with the human body Patients suffering from severe depression or any other psychological or psychiatric disease Any anatomic, physiological, or medical conditions that may increase the risks linked to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the patient Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of this clinical investigation Anything that, in the opinion of the Principal Investigator, would place the patient at increased risk or preclude the patient's full compliance with the general requirements of this clinical investigation.

Sites / Locations

  • Tirol Kliniken GmbHRecruiting
  • Medical University of ViennaRecruiting
  • Stuttgart Hospital - KatharinenhospitalRecruiting
  • University Hospital of WürzburgRecruiting
  • SRH Wald-Klinikum Gera GmbHRecruiting
  • Charité - Medical University of BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

SPIRION Laryngeal Pacemaker System Implantation and follow-up

Outcomes

Primary Outcome Measures

Device Safety
Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)
Device Performance - Respiration
PIF (Peak Inspiratory Flow) [L/min]

Secondary Outcome Measures

Voice Quality - Fundamental Frequency (F0)
F0 range [Hz]
Voice Quality - Sound Pressure Level (SPL)
SPL range [dB]
Voice Quality - Maximum Phonation Time (MPT)
MPT [s]
Voice Quality - Jitter
Jitter in percentage [%]
Voice Quality - Roughness, Breathiness, Hoarseness (RBH)
RBH - score between 0 and 3 for each characteristic, higher score indicates worse voice quality
Voice Quality - Dysphonia Severity Index (DSI)
DSI - calculated as 0,13 * MPT + 0,0053 * F0_maximal - 0,26 * SPL_minimal - 1,18 * Jitter + 12,4; the following ranges apply: abnormal voice (-5 < X ≤ 1,6); normal voice (1,6 < X ≤ 5), not evaluable (≤ -5)
Voice Quality - Voice Handicap Index (VHI)-9
VHI-9 patient questionnaire - score between 0 and 36, higher score indicates worse voice quality)
Respiratory patency - Absolute Peak Expiratory Flow (PEF)
Absolute PEF [L/min]
Respiratory patency - Normalized PEF
Normalized PEF [L/min]
Respiratory patency - Absolute Peak Inspiratory Flow (PIF)
Absolute PIF [L/min]
Respiratory patency - Normalized PIF
Normalized PIF [L/min]
Respiratory patency - Absolute Vital Capacity (VC)
Absolute VC [L]
Respiratory patency - Normalized VC
Normalized VC [L]
Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)
Absolute FEV1 [L]
Respiratory patency - Normalized FEV1
Normalized FEV1 [L]
Respiratory patency - Absolute Forced Vital Capacity (FVC)
Absolute FVC [L]
Respiratory patency - Normalized FVC
Normalized FVC [L]
Respiratory patency - Tiffeneau Index
Tiffeneau Index - calculated as (FEV1/FVC)*100
Respiratory patency - Phonation quotient (PQ)
PQ - calculated as VC/MPT [L/s]
Respiratory patency - Estimated Mean Flow Rate (EMFR)
EMFR - calculated as 77+0.236*PQ
Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)
SGRQ patient questionnaire - score between 0 and 100; higher score indicates worse health
Physical activity - 6 Minute Walk Test (6MWT)
6MWT [m]
Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)
PAL - calculated as Total Energy Expenditure [Kcal]/Basal Metabolic Rate[Kcal]
Physical activity - PAM - Activity/Rest durations
Durations of activity/inactivity/sleep measured in [h:m] and [%]
Physical activity - PAM - Movement intensity
Movement intensity [g]
Physical activity - PAM - Number of steps
Average Number of steps per 24 h
Physical activity - PAM - Times out of bed
Number of Times out of bed
Swallow quality
MD Anderson Dysphagia Inventory (MDADI) patient questionnaire - total score between 20 and 100, higher score indicates better day-to-day functioning
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) patient questionnaire - score between 0 and 21; higher score indicates worse sleep quality
Participant's Quality of Life - Short Form-36 (SF-36) questionnaire
SF-36 patient questionnaire - score between 0 and 100, higher score indicates better health
Participant's Quality of Life - Glasgow Benefit Inventory (GBI)
GBI patient questionnaire - score between -100 and 100, negative scores indicate a poor outcome, positive scores indicate a good outcome
Symptoms
Symptom form - Log of symptoms and symptom severity during visits, descriptive evaluation
Symptoms and Patient Observations
Weekly Journal - Log of symptoms, symptom severity, and device use at home, descriptive evaluation

Full Information

First Posted
July 26, 2023
Last Updated
October 2, 2023
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT06007144
Brief Title
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement
Official Title
Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients With Previous Permanent Glottal Enlargement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MED-EL Elektromedizinische Geräte GesmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical investigation is to learn about the use of a novel medical device, the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis (BVFP) and who have had at least one related surgery on one of their vocal folds. The main questions it aims to answer are: Is the use of the device safe? Does the device improve the participants ability to take a breath? Participants will be implanted with the SPIRION Laryngeal Pacemaker and the development of their symptoms will be observed for the following 2 years.
Detailed Description
This clinical investigation aims to assess the long-term safety and performance of the SPIRION Laryngeal Pacemaker. The SPIRION Laryngeal Pacemaker is a new active implantable medical device designed and developed by MED-EL Elektromedizinische Geräte GmbH. It is currently in its pre-market approval phase and the results of this clinical investigation will be used to apply for EU market entry. The SPIRION Laryngeal Pacemaker is intended to improve the symptoms of Bilateral Vocal Fold Paralysis (BVFP) patients with respiratory symptoms severe enough to require surgical treatment. The SPIRION Laryngeal Pacemaker consists of 2 implantable (the SPIRION Electrode and the SPIRION Implant) and 1 external (the SPIRION Processor) components. The SPIRION Electrodes and the SPIRION Implant are placed subcutaneously in the neck and above the sternum, respectively. The SPIRION Processor is placed on the skin above the sternum. The external SPIRION Processor transmits the stimulation parameters to the SPIRION Implant, which in turn transmits the stimulation via the SPIRION Electrode to the posterior cricoarytenoid muscle (PCA). The PCA stimulation induces the lateralization (abduction) of the respective vocal fold (VF) and thus increases the glottal gap and improves respiratory patency. Each patient is foreseen to actively participate in this clinical investigation for a maximum of 28 months. Patients will be offered participation by their ear, nose, and throat specialist. In case a patient is interested, a thorough Informed consent process will be initiated. Patients will be tested for eligibility and if they pass, the baseline values regarding respiration, voice, and other symptoms will be recorded. A few days to weeks later, the SPIRION Laryngeal Pacemaker is implanted. The Implant is activated about 2 to 4 weeks after a successful implantation and is fitted to the individual needs of the patient. Subsequent follow-up (FU) visits are conducted after about 1, 3, 6, 9, 12, 18, and 24 months after the activation of the device. The results of the various tests meant to assesses the patients' quality of respiration, voice, and other symptoms are recorded. The SPIRION Laryngeal Pacemaker will be transiently deactivated twice between 12 and 24 months after activation. Tests will be performed in this period and compared with the previous and subsequent tests performed with the active device. In addition, patients' activity before implantation and during the 24-month FU period will be regularly assessed. Upon study conclusion, the patients will be actively followed-up every 6 months until the SPIRION Laryngeal Pacemaker receives a CE certification, or it is surgically removed. The implantation of the SPIRION Laryngeal Pacemaker should generally improve the BVFP symptoms of patients regarding respiration, swallowing, and sleep quality. Voice quality should not be affected or even improve. Moderate physical activity (e.g., using an E-bike) should become possible, leading to an improved general quality of life. Unlike surgical glottal enlargement, the implantation of the SPIRION Laryngeal Pacemaker should not lead to problems with swallowing and aspiration. In addition, it should lead to a lesser rate and /or severity of surgical complications and surgery-related side-effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Vocal Cord Paralysis
Keywords
Bilateral Vocal Fold Paralysis, BVFP, Bilateral Vocal Cord Paralysis, BVCP, Laryngeal Pacemaker, Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
SPIRION Laryngeal Pacemaker System Implantation and follow-up
Intervention Type
Device
Intervention Name(s)
SPIRION Laryngeal Pacemaker System Implantation and follow-up
Intervention Description
Timeline of Visits Screening Baseline: Official baseline, assessment primary & secondary objectives Implantation of device Activation & fitting: Baseline active device; implanted device has just been activated; assessment of secondary objectives only 8 FU Visits over 2 years after activation; Includes Baseline Switch Off: results of the visit preceding a 14-day switch-off of the device; assessment of secondary objectives only Endpoints for Pivotal phase: 12 months after activation; official endpoint for assessment of primary & secondary objectives Active post-pivotal phase: 24-month follow-up; endpoint for all secondary objectives Switch Off: 2 Visits; assessment of secondary objectives only Repeated checkpoints to assess device effects over 2 years: 5 visits; assessment of secondary objectives only Device shall increase respiratory patency during inspiration, assessed by normalized PIF; other outcome measures are used to assess secondary objectives
Primary Outcome Measure Information:
Title
Device Safety
Description
Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)
Time Frame
12 Months
Title
Device Performance - Respiration
Description
PIF (Peak Inspiratory Flow) [L/min]
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Voice Quality - Fundamental Frequency (F0)
Description
F0 range [Hz]
Time Frame
24 months
Title
Voice Quality - Sound Pressure Level (SPL)
Description
SPL range [dB]
Time Frame
24 months
Title
Voice Quality - Maximum Phonation Time (MPT)
Description
MPT [s]
Time Frame
24 months
Title
Voice Quality - Jitter
Description
Jitter in percentage [%]
Time Frame
24 months
Title
Voice Quality - Roughness, Breathiness, Hoarseness (RBH)
Description
RBH - score between 0 and 3 for each characteristic, higher score indicates worse voice quality
Time Frame
24 months
Title
Voice Quality - Dysphonia Severity Index (DSI)
Description
DSI - calculated as 0,13 * MPT + 0,0053 * F0_maximal - 0,26 * SPL_minimal - 1,18 * Jitter + 12,4; the following ranges apply: abnormal voice (-5 < X ≤ 1,6); normal voice (1,6 < X ≤ 5), not evaluable (≤ -5)
Time Frame
24 months
Title
Voice Quality - Voice Handicap Index (VHI)-9
Description
VHI-9 patient questionnaire - score between 0 and 36, higher score indicates worse voice quality)
Time Frame
24 months
Title
Respiratory patency - Absolute Peak Expiratory Flow (PEF)
Description
Absolute PEF [L/min]
Time Frame
24 months
Title
Respiratory patency - Normalized PEF
Description
Normalized PEF [L/min]
Time Frame
24 months
Title
Respiratory patency - Absolute Peak Inspiratory Flow (PIF)
Description
Absolute PIF [L/min]
Time Frame
24 months
Title
Respiratory patency - Normalized PIF
Description
Normalized PIF [L/min]
Time Frame
24 months
Title
Respiratory patency - Absolute Vital Capacity (VC)
Description
Absolute VC [L]
Time Frame
24 months
Title
Respiratory patency - Normalized VC
Description
Normalized VC [L]
Time Frame
24 months
Title
Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)
Description
Absolute FEV1 [L]
Time Frame
24 months
Title
Respiratory patency - Normalized FEV1
Description
Normalized FEV1 [L]
Time Frame
24 months
Title
Respiratory patency - Absolute Forced Vital Capacity (FVC)
Description
Absolute FVC [L]
Time Frame
24 months
Title
Respiratory patency - Normalized FVC
Description
Normalized FVC [L]
Time Frame
24 months
Title
Respiratory patency - Tiffeneau Index
Description
Tiffeneau Index - calculated as (FEV1/FVC)*100
Time Frame
24 months
Title
Respiratory patency - Phonation quotient (PQ)
Description
PQ - calculated as VC/MPT [L/s]
Time Frame
24 months
Title
Respiratory patency - Estimated Mean Flow Rate (EMFR)
Description
EMFR - calculated as 77+0.236*PQ
Time Frame
24 months
Title
Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)
Description
SGRQ patient questionnaire - score between 0 and 100; higher score indicates worse health
Time Frame
24 months
Title
Physical activity - 6 Minute Walk Test (6MWT)
Description
6MWT [m]
Time Frame
24 months
Title
Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)
Description
PAL - calculated as Total Energy Expenditure [Kcal]/Basal Metabolic Rate[Kcal]
Time Frame
24 months
Title
Physical activity - PAM - Activity/Rest durations
Description
Durations of activity/inactivity/sleep measured in [h:m] and [%]
Time Frame
24 months
Title
Physical activity - PAM - Movement intensity
Description
Movement intensity [g]
Time Frame
24 months
Title
Physical activity - PAM - Number of steps
Description
Average Number of steps per 24 h
Time Frame
24 months
Title
Physical activity - PAM - Times out of bed
Description
Number of Times out of bed
Time Frame
24 months
Title
Swallow quality
Description
MD Anderson Dysphagia Inventory (MDADI) patient questionnaire - total score between 20 and 100, higher score indicates better day-to-day functioning
Time Frame
24 months
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) patient questionnaire - score between 0 and 21; higher score indicates worse sleep quality
Time Frame
24 months
Title
Participant's Quality of Life - Short Form-36 (SF-36) questionnaire
Description
SF-36 patient questionnaire - score between 0 and 100, higher score indicates better health
Time Frame
24 months
Title
Participant's Quality of Life - Glasgow Benefit Inventory (GBI)
Description
GBI patient questionnaire - score between -100 and 100, negative scores indicate a poor outcome, positive scores indicate a good outcome
Time Frame
24 months
Title
Symptoms
Description
Symptom form - Log of symptoms and symptom severity during visits, descriptive evaluation
Time Frame
24 months
Title
Symptoms and Patient Observations
Description
Weekly Journal - Log of symptoms, symptom severity, and device use at home, descriptive evaluation
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General information The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria: Patients recruited in the previous first-in-human (FIH) clinical investigation 2011CIP001 Patients with an open tracheostoma at the time of enrolment Inclusion Criteria: Between 18 and 75 years old at the time of enrolment (i.e., informed consent form (ICF) signed) Diagnosed with BVFP for a minimum of 6 months Patients who underwent at least one permanent glottal enlargement. If revision surgeries were performed, they should have been conducted on the same side of the original surgery With sufficient autonomous respiratory capacity to maintain their vital functions independent of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the tracheostomy is carried out during this clinical investigation, the Principal Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal Pacemaker would not put the patient in a life-threatening condition because of insufficient respiratory patency The PCA innervating the vocal fold that never underwent a permanent glottal enlargement responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an Endoscopic Cap Electrode (ECE50) test, or shows reinnervation in an laryngeal electromyography (LEMG) assessment Fluent in German. Exclusion Criteria: Lack of compliance with any inclusion criteria Pregnant or breast-feeding women Patients suffering from an ongoing or chronic laryngeal inflammation at the time of enrolment Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, central nervous system (CNS) pathologies, and/or systemic diseases Patients who underwent previous bilateral permanent surgical glottal enlargement Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework surgery) that would compromise the correct SPIRION Electrode placement and/or the intended functionality of the SPIRION Laryngeal Pacemaker The adductor laryngeal muscles on either or both sides underwent a botulinum toxin injection that is still effective at the time of surgery (i.e., the respective VF position is either in intermediate or lateral position) Patients who underwent thoracic surgeries that would compromise at least one of the following procedures: Correct placement of the SPIRION Electrode or SPIRION Implant Connection of the SPIRION Implant with the SPIRION Electrode Connection of the SPIRION Implant with the external SPIRION Processor Patients wearing an active implantable medical device at the time of enrolment Patients with a clinical history that would suggest a high probability that they would need an MRI Patients diagnosed with a malignant disease in the head and neck region Patients diagnosed with chronic airway infections or obstructions, or severe respiratory diseases (e.g., chronic obstructive pulmonary disease (COPD) grade II or higher) Patients who underwent external beam radiation therapy in the surgical area Patients diagnosed with a serious coagulation disorder requiring an uninterruptable use of anticoagulants Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct contact with the human body Patients suffering from severe depression or any other psychological or psychiatric disease Any anatomic, physiological, or medical conditions that may increase the risks linked to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the patient Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of this clinical investigation Anything that, in the opinion of the Principal Investigator, would place the patient at increased risk or preclude the patient's full compliance with the general requirements of this clinical investigation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pia Plattner, MSc.
Phone
+43 664 607 051 681
Email
pia.plattner@medel.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Rubiolo, PhD
Phone
+43 664 607 055 556
Email
cristina.rubiolo@medel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Müller, Prof. Dr.
Organizational Affiliation
SRH Wald-Klinikum Gera GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berit Schneider-Stickler, Prof. Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Mürbe, Prof. Dr.
Organizational Affiliation
Charité - Medical University of Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claus Potoschnig, Univ-Doz.Dr.
Organizational Affiliation
Tirol Kiniken GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan-Constantin Kölmel, Dr.
Organizational Affiliation
Stuttgart Hospital - Katharinenhospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rudolf Hagen, Prof. Dr.Dr.
Organizational Affiliation
University Hospital of Würzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tirol Kliniken GmbH
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Potoschnig, Univ-Doz.Dr.
Phone
+43 512 504 81876
Email
claus.pototschnig@tirol-kliniken.at
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berit Schneider-Stickler, Prof. Dr.
Phone
+43 140 400 33100
Email
berit.schneider-stickler@meduniwien.ac
Facility Name
Stuttgart Hospital - Katharinenhospital
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70174
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Constantin Kölmel, Dr.
Phone
+49 711 278 33270
Email
c.koelmel@klinikum-stuttgart.de
Facility Name
University Hospital of Würzburg
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudolf Hagen, Prof. Dr.Dr.
Phone
+49 931 201 21701
Email
hagen_r@ukw.de
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07548
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Müller, Prof. Dr.
Phone
+49 365 828 2650
Email
andreas.mueller@srh.de
Facility Name
Charité - Medical University of Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Mürbe, Prof. Dr.
Phone
+49 30 450 555 402
Email
dirk.muerbe@charite.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement

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