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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02263859
The ClinicalTrials.gov registry entry for NCT02263859 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (38% lower). The listed sponsor is ImThera Medical, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.