Status:
COMPLETED
Targeted Hypoglossal Neurostimulation Study #2
Lead Sponsor:
ImThera Medical, Inc.
Conditions:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
Eligibility Criteria
Inclusion
- AHI \>20
- Noncompliant to CPAP
- Willing to provide informed consent
- Willing to comply with all follow-up visits and evaluations
Exclusion
- BMI limits
- COPD
- Central Sleep Apnea
- Anatomic variations interfering with device placement or stability.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01796925
Start Date
February 1 2013
End Date
September 1 2014
Last Update
August 12 2019
Active Locations (9)
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1
Sharp Rees Stealy Medical Center
San Diego, California, United States, 92123
2
Porter Adventist Hospital
Denver, Colorado, United States, 80210
3
Chicago ENT
Chicago, Illinois, United States, 60657
4
Orange Regional Medical Center
Middletown, New York, United States, 10940