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NCT00010374 · ClinicalTrials.gov registry record · NA

Electrical Activation of The Diaphragm for Ventilatory Assist

A NA study, sponsored by Synapse Biomedical.

Completed
Registry status
NA
Development phase
54
Enrollment target

NCT00010374: Completed NA study, sponsored by Synapse Biomedical.

NCT00010374 is a NA study that has completed, run by Synapse Biomedical. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00010374, a NA study, has completed, sponsored by Synapse Biomedical.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target

Study 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.

Primary Outcome

Number of enrolled subjects that successfully maintained clinically acceptable tidal volumes greater than basal requirements over a continuous 4 hour period.

Interventions

  • DEVICE NeuRx DPS

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2000-02
Est. Completion 2008-10
Phase NA
Synapse Biomedical

4 total trials

What the finished NCT00010374 record still lists

NCT00010374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which NeuRx DPS is the first listed.

NCT00010374 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00010374 about?

NCT00010374 is a clinical study titled "Electrical Activation of The Diaphragm for Ventilatory Assist". 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 ...

What is the current status of trial NCT00010374?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2000-02. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00010374?

The interventions under investigation include: NeuRx DPS (DEVICE).

Who is sponsoring clinical trial NCT00010374?

This trial is sponsored by Synapse Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00010374's enrollment target sits among peer trials

54 1268th of 2000 higher than 730 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00010374, the US trial registry maintained by the National Library of Medicine. NCT00010374 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.