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Electrical Activation of The Diaphragm for Ventilatory Assist

NCT00010374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-08-18

Study results available
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Summary

OBJECTIVES:

The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.

Conditions

  • Spinal Cord Injury
  • Quadriplegia

Interventions

DEVICE

NeuRx DPS

Laparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS.

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • Shepherd Center, Atlanta GA

    collaborator OTHER

  • Synapse Biomedical

    lead INDUSTRY

Principal Investigators

  • Raymond Onders, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Canada

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 NCT00010374 on ClinicalTrials.gov