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

Synapse Biomedical

Status: Completed

Conditions: Chronic Obstructive Airway Disease

Treatments: Device: NeuRx Diaphragm Pacing System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02411383

CLIN 20-1000-0001

Details and patient eligibility

About

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.

Full 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)

Enrollment: 4 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

NeuRx Diaphragm Pacing System (DPS)®

Experimental group

Description:

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

Treatment:

Device: NeuRx Diaphragm Pacing System