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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: Completed NA study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Synapse Biomedical.
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 297-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (67% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* Serious capnothorax requiring invasive intervention * Mechanical ventilation for 24 hours or longer post-procedure * Post-procedure extubation failure resulting in permanent tracheostomy ventilation * Perioperative complication which delays initiation of NeuRx DPS therapy * Severe discomfort due to stimulation which is unable to be tolerated or resolved * Device malfunction which interrupts or causes an undesired diminution of NeuRx DPS therapy * Electrode dislodgement from the diaphragm * Wir
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-02 |
| Phase | NA |
What the finished NCT01605006 record still lists
NCT01605006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 297-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (67% lower).
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 lists 11 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis (ALS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01605006's enrollment target sits among peer trials
97 10th of 18 higher than 9 of 18 other Amyotrophic Lateral Sclerosis (ALS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis (ALS) 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.
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