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NCT01605006 · ClinicalTrials.gov registry record · NA

Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis

A NA study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Synapse Biomedical.

Completed
Registry status
NA
Development phase
97
Enrollment target
11
Study locations

NCT01605006 is a NA study of Amyotrophic Lateral Sclerosis (ALS) that has completed, run by Synapse Biomedical. The registered enrollment target is 97 participants, below the 255-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (62% lower). The trial reports 11 study locations across 10 states.

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The verdict

NCT01605006, a NA study of Amyotrophic Lateral Sclerosis (ALS), has completed, sponsored by Synapse Biomedical.

COMPLETED
Registry status
NA
Development phase
97 participants
Enrollment target
11
Study locations

Study Summary

This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures will be assessed.

Conditions Studied

Amyotrophic Lateral Sclerosis (ALS)

Interventions

  • DEVICE NeuRx Diaphragm Pacing System (DPS)

Study Locations (11)

California

  • Cedars-Sinai Medical Center - Los Angeles
  • California Pacific Medical Center -- Forbes Norris MDA/ALS Research Center - San Francisco

Colorado

  • University of Colorado Denver - Denver

Florida

  • Mayo Clinic - Jacksonville

Illinois

  • Northwestern University - Chicago

Kansas

  • University of Kansas Medical Center - Kansas City

Nebraska

  • University of Nebraska Medical Center - Omaha

New York

  • Stony Brook University - Stony Brook

North Carolina

  • Duke University - Durham

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2012-07
Est. Completion 2017-02
Phase NA

Sponsor

Synapse Biomedical

4 total trials

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What the Registry Record Tells You About NCT01605006

The ClinicalTrials.gov registry entry for NCT01605006 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (62% lower). The listed sponsor is Synapse Biomedical, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amyotrophic Lateral Sclerosis (ALS) appearing as the primary indexed condition, and to 1 intervention - of which NeuRx Diaphragm Pacing System (DPS) is the first listed.

NCT01605006 reports 11 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT01605006 about?

NCT01605006 is a clinical study titled "Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis". This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the d...

What is the current status of trial NCT01605006?

This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2012-07. Estimated completion is 2017-02.

What conditions does trial NCT01605006 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (ALS).

What interventions are being tested in trial NCT01605006?

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

Who is sponsoring clinical trial NCT01605006?

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

Where is trial NCT01605006 being conducted?

This trial has 11 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.