Status:
TERMINATED
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
Lead Sponsor:
Nyxoah S.A.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
Eligibility Criteria
Inclusion
- Diagnosed with moderate to severe Obstructive Sleep Apnea
- Have failed or have not tolerated CPAP treatment
- Willing and capable of providing informed consent
- Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Exclusion
- BMI limits
- Subjects with complete concentric collapse at the soft palate level per endoscopy
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02312479
Start Date
December 1 2014
End Date
April 1 2016
Last Update
September 27 2016
Active Locations (2)
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1
Antwerp University Hospital
Edegem, Belgium
2
Universitäts-HNO-Klinik Mannheim
Mannheim, Germany