CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 198 enrolled
Drug / intervention
Medical Management +1 moredrug
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/NCT01685229
NCT01685229N/ACompleted

Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)

Integra LifeSciences Corporation·observational·Posted Sep 14, 2012·Updated Jul 12, 2024

In Brief

An observational study evaluating Balloon sinus dilation and Medical Management for Sinusitis. Completed, enrolled 198 participants across 20 sites.

Detailed Summary

This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesUnited States
CollaboratorsAcclarent

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartSep 1, 2012
Primary CompletionApr 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.8 years ago

Interventions

Balloon sinus dilationdevice

Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.

Medical Managementdrug

Subjects who select to continue on medical management rather than have a BSD procedure.