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Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation

Primary Purpose

Chronic Obstructive Airway Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
NeuRx Diaphragm Pacing System
Sponsored by
Synapse Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Airway Disease focused on measuring Diaphragm pacing, Respiratory assistance, Lung transplant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is undergoing bilateral lung transplantation
  • Signed written informed consent has been obtained prior to any study related procedure

Exclusion Criteria:

  • Diaphragm malformation which makes the electrode insertion impossible
  • Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
  • Participation in other clinical studies that could interfere with the results in the ongoing study

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeuRx Diaphragm Pacing System (DPS)®

Arm Description

The NeuRx Diaphragm Pacing System (DPS)® is placed in the diaphragm during lung transplant.

Outcomes

Primary Outcome Measures

Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
Tolerability: Patient withdrawal from treatment.
Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.

Secondary Outcome Measures

Composite endpoint
Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG).

Full Information

First Posted
April 2, 2015
Last Updated
April 12, 2016
Sponsor
Synapse Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT02411383
Brief Title
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
Official Title
Prospective, Single-centre, Open-label Clinical Study to Investigate the Safety and Performance of the NeuRx Diaphragm Pacing System (DPS) in Patients Undergoing Bilateral Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synapse Biomedical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.
Detailed Description
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. The objectives are to evaluate the safety and technical performance of DPS by assessing: the immediate safety and technical surgical results of implantation the safety and tolerability of use and removal until patient discharge from the Intensive Care Unit (ICU) or hospital the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Airway Disease
Keywords
Diaphragm pacing, Respiratory assistance, Lung transplant

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NeuRx Diaphragm Pacing System (DPS)®
Arm Type
Experimental
Arm Description
The NeuRx Diaphragm Pacing System (DPS)® is placed in the diaphragm during lung transplant.
Intervention Type
Device
Intervention Name(s)
NeuRx Diaphragm Pacing System
Intervention Description
NeuRx Diaphragm Pacing System electrodes are placed in the diaphragm during lung transplant surgery. The diaphragm will be continually paced until the patient is free from the ventilator or the patient is discharged from the ICU whichever. Diaphragm measurements are taken daily to assess tolerability and pacing success.
Primary Outcome Measure Information:
Title
Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
Time Frame
30 days
Title
Tolerability: Patient withdrawal from treatment.
Time Frame
30 days
Title
Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Composite endpoint
Description
Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG).
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is undergoing bilateral lung transplantation Signed written informed consent has been obtained prior to any study related procedure Exclusion Criteria: Diaphragm malformation which makes the electrode insertion impossible Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma Participation in other clinical studies that could interfere with the results in the ongoing study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dries Testelmans, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation

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