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

NCT04031040 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-04

No results posted yet for this study

Summary

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.

Conditions

Interventions

DEVICE

Genio® system therapy

Hypoglossal nerve stimulation system

Sponsors & Collaborators

  • Nyxoah S.A.

    lead INDUSTRY

Principal Investigators

  • Joachim T. Maurer, MD · Klinik für HNO-Heilkunde, Mannheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2026-10-30
Completion
2030-10-31

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031040 on ClinicalTrials.gov