A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults (EliSA)
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- STATUS
- Recruiting
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- End date
- Oct 30, 2025
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- participants needed
- 110
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- sponsor
- Nyxoah S.A.
Summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.
Description
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
Details
| Condition | Obstructive Sleep Apnea |
|---|---|
| Treatment | Genio(TM) system therapy |
| Clinical Study Identifier | NCT04031040 |
| Sponsor | Nyxoah S.A. |
| Last Modified on | 21 March 2022 |
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