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NCT01161420 · ClinicalTrials.gov registry record · Phase 3
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
A Phase 3 study, sponsored by Inspire Medical Systems.
- Completed
- Registry status
- Phase 3
- Development phase
- 929
- Enrollment target
NCT01161420 is a Phase 3 study that has completed, run by Inspire Medical Systems. The registered enrollment target is 929 participants.
The verdict
NCT01161420, a Phase 3 study, has completed, sponsored by Inspire Medical Systems.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 929 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.
Interventions
- DEVICE Inspire Upper Airway Stimulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 929 participants |
| Start Date | 2010-07 |
| Est. Completion | 2017-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161420
The ClinicalTrials.gov registry entry for NCT01161420 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 929 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inspire Medical Systems, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Inspire Upper Airway Stimulation System is the first listed.
NCT01161420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01161420 about?
NCT01161420 is a clinical study titled "Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)". The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study...
What is the current status of trial NCT01161420?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 929 participants. The study started on 2010-07. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01161420?
The interventions under investigation include: Inspire Upper Airway Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT01161420?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
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