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Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)

NCT03107949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-05-10

No results posted yet for this study

Summary

An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for \> or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.

Conditions

  • Ventilator Induced Diaphragm Dysfunction

Interventions

DEVICE

Lungpacer DPTS (Diaphragm Pacing Therapy System)

Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Lungpacer Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Linda Clark, RN, BSN · Vice Presdient of Clinical Affairs, Lungpacer Medical, Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2018-01-30
Completion
2018-02-18
FDA Device
Yes

Countries

  • United States

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 NCT03107949 on ClinicalTrials.gov