Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 9:31 AM
Study NCT ID:
NCT03048604
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2017-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Sponsor:
Nyxoah S.A.
Organization:
Study Overview
Official Title:
A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: