CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
RFA treatmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02349893
NCT02349893N/ACompleted
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Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

Olympus Surgical Technologies Europe·interventional·Posted Jan 29, 2015·Updated Jul 19, 2022

In Brief

A clinical study evaluating RFA treatment for Apnea, Sleep. Completed, enrolled 56 participants across 6 sites.

Detailed Summary

The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents. This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsApnea, Sleep
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 29, 2015
Enrollment StartFeb 1, 2015
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 11.4 years ago

Interventions

RFA treatmentdevice

RFA treatment using CelonProSleep plus system