An Extension Study to Assess the Long-term Safety of the Genio® System

Launched by NYXOAH S.A. · Jul 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into the long-term safety of the Genio® system, a treatment for adults with obstructive sleep apnea (OSA). The main goal is to find out how safe this device is for people who have already received it, whether they are currently using it or not. Participants will share any serious problems or issues they've experienced with the device during their routine follow-up visits.

To be eligible for this study, participants must have previously consented to be a part of a Nyxoah-sponsored clinical investigation and currently have a Genio® Implantable Stimulator (IS) in place. There are no specific exclusions, which means most adults who fit the inclusion criteria can participate. It's important for potential participants to know that they will be actively reporting their experiences, contributing to a better understanding of the device's long-term safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject voluntarily signed an Informed Consent Form
• • Subject is currently implanted with a Genio® Implantable Stimulator (IS), with therapy active or inactive, and was included in and subsequently exited a Nyxoah sponsored clinical investigation (either by study completion or withdrawal). These studies include, but are not limited to BLAST OSA (CL-GEN-001203), BETTER SLEEP (CL-GEN-001908), DREAM (CL-GEN-002033) or, subject is currently implanted with a Genio® Implantable Stimulator (IS) and accessing therapy via the TGA special access scheme (SAS).
• Exclusion Criteria:
• • None