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A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults — EliSA  

Obstructive Sleep Apnea Clinical Trial

Official title:
A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04031040
Study type Interventional
Source Nyxoah S.A.
Contact Jey Subbaroyan, PhD
Phone +1 (734) 277-3273
Email Jey.Subbaroyan@Nyxoah.com
Status Recruiting
Phase N/A
Start date September 1, 2019
Completion date October 30, 2025
View Details
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