Clinical trial NCT01685229: Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Official title: Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2012-09-14
Enrollment: 198
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects age 19 or older with radiographically documented CRS

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 19 or greater
* Diagnosis of Chronic Rhinosinusitis (CRS)
* Failure of appropriate medical management
* Radiographic evidence of inflammation of the paranasal sinuses
* Surgical candidate
* Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures
* Able to read and understand English

Exclusion Criteria:

* Not suitable for balloon dilation for all peripheral sinuses that require treatment
* Clinically significant illness that may interfere with the evaluation of the study
* Patients involved in other clinical studies 30 days prior to study
* Pregnant or lactating females
* Patients unable to adhere to follow-up schedule or protocol requirements

Primary outcomes:
measure: Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline
timeFrame: 24 weeks post treatment
Secondary outcomes:
measure: Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline
timeFrame: 12, 24, and 52 weeks post treatment
measure: Change in RSDI
timeFrame: 12, 24 and 52 weeks post treatment
measure: Change in SNOT-20
timeFrame: 12 weeks, 24 weeks, 52 weeks post treatment
measure: Change in Disease-specific Medication Usage
timeFrame: 12, 24 and 52 weeks post treatment
measure: Missed Days Work/School
timeFrame: 12, 24 and 52 weeks post treatment
measure: Number of Sinus-related Medical Care Visits
timeFrame: 12 weeks, 24 weeks, 52 weeks post treatment
measure: Number of Sinus Infections
timeFrame: 24 and 52 weeks
measure: Number of Subjects Requiring Revision for Subjects Electing BSD
timeFrame: 52 weeks
measure: Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure
timeFrame: 52 weeks
measure: Post-operative Return to Normal Activity (RTNA)
timeFrame: 2 weeks post treatment
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Vidalia
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Neptune
country: United States
state: New Jersey
city: Dublin
country: United States
state: Ohio
city: Frisco
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Beaver Dam
country: United States
state: Wisconsin
city: Wauwatosa
country: United States
state: Wisconsin
Study officials:
affiliation: University of Virginia
name: Spencer Payne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia Nasal and Sinus Institute
name: Christopher Melroy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio Sinus Institute
name: Boris Karanfilov, MD
role: PRINCIPAL_INVESTIGATOR
References: