Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
Public ClinicalTrials.gov record NCT01605006. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
HDE Post-Approval Study (PAS) of NeuRx DPS for ALS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01605006
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2012
- Primary completion
- Jan 31, 2017
- Completion
- Jan 31, 2017
- Last update posted
- Mar 26, 2020
2012 – 2017
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| California Pacific Medical Center -- Forbes Norris MDA/ALS Research Center | San Francisco | California | 94115 | — |
| University of Colorado Denver | Denver | Colorado | 80045 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01605006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01605006 live on ClinicalTrials.gov.