REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02180815
• Other study ID #: REV 002
• Status: Terminated
• Phase: N/A
• First received: June 11, 2014
• Last updated: March 30, 2017
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: March 2017
• Source: Revent Medical International B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.

• AHI = 10 and AHI = 40 (at least 90% of apneas and hypopneas must be obstructive).

• BMI = 32.

• Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).

Exclusion Criteria:

• Patient with prior tongue-base surgery

• Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.

• History of mandibular and/or hyoid advancement to treat OSA.

• Any contraindications as listed in the approved Instructions for Use.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ReVENT Sleep Apnea System

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	University Hospital Antwerp	Edegem
Czech Republic	Pavelec LENTE, Ltd.	Plzen
Germany	St Joseph-Stift	Bremen
Germany	Alfried Krupp Krankenhaus	Essen
Germany	Asklepios Klinik Harburg	Hamburg
Germany	St. Franziskus Hospital HNO-Klinik	Köln
Germany	Universitäts-HNO-Klinik Mannheim	Mannheim
Germany	Klinikum Ernst von Bergmann	Potsdam
Germany	Universitätsklinikum HNO-Klinik	Ulm
Netherlands	MC Slotervaart	Amsterdam
Netherlands	Sint Antonius Hospital	Nieuwegein
Netherlands	ISALA Afdeling KNO-Heelkunde Isala	Zwolle
Switzerland	Cantonal Hospital Baselland - ENT Department	Liestal

Sponsors (2)

Lead Sponsor	Collaborator
Revent Medical International B.V.	Revent Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety profile assessed by incidence of adverse events		1 week, 6 and 12 months
Primary	Reduction in Apnea-Hypopnea Index (AHI)		3, 6 and 12 months
Secondary	Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life		3, 6 and 12 months