NCT02411383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 2, 2015

Last Update Submit

April 12, 2016

Conditions

Chronic Obstructive Airway Disease

Keywords

Diaphragm pacingRespiratory assistanceLung transplant

Outcome Measures

Primary Outcomes (3)

  • Safety: Daily assessment of device or procedure-related adverse events until patient discharge.

    30 days

  • Tolerability: Patient withdrawal from treatment.

    30 days

  • Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.

    30 days

Secondary Outcomes (1)

  • Composite endpoint

    30 days

Study Arms (1)

NeuRx Diaphragm Pacing System (DPS)®

EXPERIMENTAL

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

Device: NeuRx Diaphragm Pacing System

Interventions

NeuRx Diaphragm Pacing SystemDEVICE

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.

NeuRx Diaphragm Pacing System (DPS)®

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dries Testelmans, MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 8, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

BE(1)