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NCT01938495 · ClinicalTrials.gov registry record · Phase 2
Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Barrow Neurological Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01938495 is a Phase 2 study that has completed, run by Barrow Neurological Institute. The registered enrollment target is 52 participants.
The verdict
NCT01938495, a Phase 2 study, has completed, sponsored by Barrow Neurological Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function. The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) to diaphragm stimulator treatment with the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival. The secondary objective of the study is to conduct a multi-center, randomized controlled clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with hypoventilation.
Interventions
- DEVICE NeuRx® Diaphragm Pacing System™ (DPS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01938495
The ClinicalTrials.gov registry entry for NCT01938495 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barrow Neurological Institute, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NeuRx® Diaphragm Pacing System™ (DPS) is the first listed.
NCT01938495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01938495 about?
NCT01938495 is a clinical study titled "Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)". The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function. The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) t...
What is the current status of trial NCT01938495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2013-08. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01938495?
The interventions under investigation include: NeuRx® Diaphragm Pacing System™ (DPS) (DEVICE).
Who is sponsoring clinical trial NCT01938495?
This trial is sponsored by Barrow Neurological Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.
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