Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05939141




Registration number
NCT05939141
Ethics application status
Date submitted
16/06/2023
Date registered
11/07/2023
Date last updated
11/07/2023

Titles & IDs
Public title
An Extension Study to Assess the Long-term Safety of the Genio® System
Scientific title
A Prospective, Open-label, Multicentric Extension Study to Assess the Long-term Safety of the Genio® System in Study Subjects Who Have Been Implanted With the Genio® Implantable Stimulator (IS) for the Treatment of OSA in Adult Patients.
Secondary ID [1] 0 0
CL-OLE2023
Universal Trial Number (UTN)
Trial acronym
OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea of Adult 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Genio System

OLE Subjects - adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation and having the device in-situ at the time of enrollment (with therapy activated or de-activated).


Treatment: Devices: Genio System
All participants have previously been implanted with a Genio® system implantable stimulator. This research is observational in nature (long term safety follow-up) and participants will not be exposed to additional procedures.
The Genio System comprises of a bilateral Implantable Stimulator (IS), which is implanted via a minimally invasive surgery procedure and positioned over the genioglossus muscle with its electrodes positioned over both the left and right hypoglossal nerve branches. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. The Implantable Stimulator receives energy pulses transmitted via the DP placed under the patient's chin and connected to the Activation Chip (AC), which contains the patient's stimulation parameters and contain a battery that provides energy.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-term safety
Timepoint [1] 0 0
Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"

Eligibility
Key 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).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/07/2028
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Woolcock Institute Of Medical Research - Sydney
Recruitment hospital [2] 0 0
Westmead Public Hospital - Sydney
Recruitment hospital [3] 0 0
Illawarra ENT and Head & Neck Clinic - Sydney
Recruitment hospital [4] 0 0
Complete ENT - Brisbane
Recruitment hospital [5] 0 0
Institute for Breathing and Sleep (IBAS) - Melbourne
Recruitment hospital [6] 0 0
Monash Health - Department of Respiratory and Sleep Medicine - Melbourne
Recruitment hospital [7] 0 0
Perth Head & Neck Surgery - Perth
Recruitment postcode(s) [1] 0 0
2037 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
2500 - Sydney
Recruitment postcode(s) [4] 0 0
4000 - Brisbane
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3168 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nyxoah S.A.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Nyxoah Pty. Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess the long-term safety of the Genio® system in adult
OSA patients with and without complete concentric collapse of the soft palate who have
successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation.

(Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted
with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy
activated or deactivated) will be collected.

The main question it aims to answer is: what is the long term safety profile of the Genio
System?

Participants will be asked to refer back to the site per standard of care and report on any
(Serious) Adverse Device Effects and Device Deficiencies that may have occurred.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05939141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Lewis, MBBS
Address 0 0
Perth Head & Neck Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dan Mans
Address 0 0
Country 0 0
Phone 0 0
+17633703594
Fax 0 0
Email 0 0
Dan.Mans@Nyxoah.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05939141