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Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

NCT03096639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-11-16

No results posted yet for this study

Summary

A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.

Conditions

  • Ventilator Induced Diaphragm Dysfunction

Interventions

DEVICE

Diaphragmatic Pacing Therapy DPTS

Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Lungpacer Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Linda H Clark, BSN · Vice President of Clinical Affairs, Lungpacer Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2019-12-29
Completion
2020-01-30
FDA Device
Yes

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096639 on ClinicalTrials.gov