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

Chronic Obstructive Airway Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411383
• Other study ID #: CLIN 20-1000-0001
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: April 12, 2016
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Synapse Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Airway Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• NeuRx Diaphragm Pacing System
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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Synapse Biomedical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Daily assessment of device or procedure-related adverse events until patient discharge.		30 days	Yes
Primary	Tolerability: Patient withdrawal from treatment.		30 days	No
Primary	Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.		30 days	No
Secondary	Composite endpoint	Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG).	30 days	No