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NCT02263859 · ClinicalTrials.gov registry record · NA
Targeted Hypoglossal Neurostimulation Study #3
A NA study of Obstructive Sleep Apnea, sponsored by ImThera Medical.
- Completed
- Registry status
- NA
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT02263859: Completed NA study of Obstructive Sleep Apnea, sponsored by ImThera Medical.
NCT02263859 is a NA study of Obstructive Sleep Apnea that has completed, run by ImThera Medical. The registered enrollment target is 138 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02263859, a NA study of Obstructive Sleep Apnea, has completed, sponsored by ImThera Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.
Primary Outcome
Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition. It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.
Conditions Studied
Interventions
- DEVICE aura6000 System
Study Locations (20)
Other
- Clinique Univ. Saint-Luc - Brussels
- Pitie Salpetriere - Paris
- Foch Hospital - Suresnes
- Ruprechts-Karls University - Mannheim
- Bnai Zion Medical Center - Haifa
- Hospital CUF Porto - Porto
California
- ENT Associates of San Diego - Chula Vista
- Tower ENT - Los Angeles
- SENTA Clinic - San Diego
Florida
- Ear, Nose, and Throat Associates of South Florida - Boca Raton
- Morton Plant Mease Healthcare - Safety Harbor
Georgia
- Advanced ENT Asociates - Atlanta
Indiana
- Center for ENT and Allergy - Carmel
Kentucky
- Kentucky Research Group - Louisville
Maryland
- Johns Hopkins University - Baltimore
New York
- ENT and Allergy Associates - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2015-02 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
What the finished NCT02263859 record still lists
NCT02263859 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which aura6000 System is the first listed.
NCT02263859 names 20 study sites across 12 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT02263859 about?
NCT02263859 is a clinical study titled "Targeted Hypoglossal Neurostimulation Study #3". The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.
What is the current status of trial NCT02263859?
This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2015-02. Estimated completion is 2023-09-01.
What conditions does trial NCT02263859 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT02263859?
The interventions under investigation include: aura6000 System (DEVICE).
Who is sponsoring clinical trial NCT02263859?
This trial is sponsored by ImThera Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02263859 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02263859's enrollment target sits among peer trials
138 53rd of 155 higher than 103 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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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