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APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

Primary Purpose

Paralysis, Unilateral, Vocal Cord

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
APrevent® VOIS-Implant
Sponsored by
APrevent Biotech GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paralysis, Unilateral, Vocal Cord

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female patients between 18 and 80 years
  • Diagnosed with permanent UVFP and insufficient glottal closure
  • A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-30 score >33)
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
  • Ability to co-operate with the Investigator and to comply with the requirements of the entire study
  • Availability to volunteer for the entire study duration, willing to adhere to all protocol requirements and willing and able to give informed consent for participation

Exclusion Criteria:

  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
  • Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
  • Bilateral vocal fold paralysis
  • Had injection medialization laryngoplasty with the injectable still being within the double length of the maximum resorption time frame as stated in their approval or as supported by literature.
  • Presence of structural vocal fold lesions such as polyp or nodules
  • Presence of oropharyngeal or laryngeal tumors
  • Patients with diagnosed severe obstructive sleep apnea (OSA)
  • Status post total cordectomy
  • Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
  • Status post tracheostomy
  • Presence of acute systemic infection at time of screening or shortly before surgery
  • Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
  • Severe coagulopathy
  • Females who are pregnant, lactating or planning pregnancy are excluded from the investigation
  • Patients with bil. Gr. III-IV hypertrophic tonsils
  • Diabetes mellitus with poor control and poor wound healing history

Sites / Locations

  • Cleveland Clinic
  • Medical University of ViennaRecruiting
  • SRH Wald-Klinikum GeraRecruiting
  • University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with the VOIS Implant

Outcomes

Primary Outcome Measures

Change in G-Score from GRBAS-Scale
Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation

Secondary Outcome Measures

Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
MPT will be measured in seconds using a digital stop clock. The patient will be asked to say a prolonged vowel "a" for as long as possible after maximal inspiration. The best out of three trials in seconds will be chosen for comparison.

Full Information

First Posted
November 4, 2021
Last Updated
July 19, 2023
Sponsor
APrevent Biotech GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05119842
Brief Title
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Official Title
Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
APrevent Biotech GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled.
Detailed Description
The APrevent® VOIS is intended to be permanently implanted during a type I thyroplasty in individuals suffering from permanent unilateral vocal fold paralysis of various etiologies. Four post-operative follow-up visits are planned: Week 1 (± 7 days), Week 7 (-7/+28 days), Month 6 (-14/+28 days) and Month 12 (-14/+28 days). This 2-part study will consist of Part A to assess safety of the patients and the following Part B to assess the performance (effectiveness) of the investigational device. In Part A of the study 8 patients will be enrolled sequentially within three groups (N=1, N=2, N=5). After enrolment and 1st Follow-up Visit of each group, a Local Safety Board will review safety and study data. No preliminary/interim analysis of safety and effectiveness data will be performed before the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralysis, Unilateral, Vocal Cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study will consist of two parts to assess safety, and effectiveness of the investigational device. Part A (Safety): In total 8 patients will be enrolled sequentially in three groups (N=1, N=2, N=5). An interval of at least 7 days between the groups will be left to allow the safety board to review individual patient's safety and demographic data. After completion of the first four patients and all three groups in Part A, an independent Data Safety Monitoring Board (DSMB) will recommend the initiation of study Part B based on the review of the safety data. Part B: In Part B of the study, the remaining 22 patients of the study will be enrolled non-sequentially. Part A and B (Effectiveness Population) will include: The part A patients will also be used for the confirmatory testing of the primary endpoint. At the end of the study safety of the investigational device will be assessed on patients of part A and B together.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with the VOIS Implant
Intervention Type
Device
Intervention Name(s)
APrevent® VOIS-Implant
Intervention Description
To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.
Primary Outcome Measure Information:
Title
Change in G-Score from GRBAS-Scale
Description
Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation
Time Frame
7weeks
Secondary Outcome Measure Information:
Title
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
Description
MPT will be measured in seconds using a digital stop clock. The patient will be asked to say a prolonged vowel "a" for as long as possible after maximal inspiration. The best out of three trials in seconds will be chosen for comparison.
Time Frame
7 weeks
Other Pre-specified Outcome Measures:
Title
R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
Description
R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
Time Frame
7 weeks
Title
B-Score from GRBAS-Scale (range [0…3]) from before to 7 weeks after permanent APrevent® VOIS implantation
Description
B-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female patients between 18 and 80 years Diagnosed with permanent UVFP and insufficient glottal closure A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-30 score >33) Ability to comprehend the full nature and purpose of the study, including possible risks and side effects Ability to co-operate with the Investigator and to comply with the requirements of the entire study Availability to volunteer for the entire study duration, willing to adhere to all protocol requirements and willing and able to give informed consent for participation Exclusion Criteria: Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation Bilateral vocal fold paralysis Had injection medialization laryngoplasty with the injectable still being within the double length of the maximum resorption time frame as stated in their approval or as supported by literature. Presence of structural vocal fold lesions such as polyp or nodules Presence of oropharyngeal or laryngeal tumors Patients with diagnosed severe obstructive sleep apnea (OSA) Status post total cordectomy Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction) Status post tracheostomy Presence of acute systemic infection at time of screening or shortly before surgery Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists) Severe coagulopathy Females who are pregnant, lactating or planning pregnancy are excluded from the investigation Patients with bil. Gr. III-IV hypertrophic tonsils Diabetes mellitus with poor control and poor wound healing history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berit Schneider-Stickler, Prof
Phone
+ 43-676-842 311 311
Email
office@med4com.at
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Leonhard, Dr
Phone
+43 1 404 00 - 33170
Email
matthias.leonhard@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Leonhard, Dr
Organizational Affiliation
Study principal investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berit Schneider-Stickler, Prof
Facility Name
SRH Wald-Klinikum Gera
City
Gera
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Medical Center
City
Hamburg
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

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