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

This study is currently recruiting participants.
Verified March 2014 by Acclarent
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01685229
First received: September 12, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Sinusitis
Device: Balloon sinus dilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Change in disease-specific patient-reported quality of life (QOL) [ Time Frame: 24 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disease-specific patient-reported quality of life [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
  • Change in disease-specific and general health-related quality of life [ Time Frame: 12, 24 and 52 weeks post treatment ] [ Designated as safety issue: No ]
  • Change in disease-specific medication usage [ Time Frame: 12, 24 and 52 weeks post treatment ] [ Designated as safety issue: No ]
  • Missed days work/school and medical care visits due to sinusitis [ Time Frame: 12, 24 and 52 weeks post treatment ] [ Designated as safety issue: No ]
  • Number of sinus infections [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
  • Number of subjects requiring revision [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of medical management subjects electing to cross-over to balloon sinus dilation procedure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Post-operative return to normal activity (RTNA) [ Time Frame: 2 weeks post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Balloon Sinus Dilation
Subjects with chronic sinusitis electing to have a balloon sinus dilation
Device: Balloon sinus dilation
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.
Other Name: Acclarent Balloon Sinuplasty System
Medical Management
Subjects with chronic sinusitis electing to continue with medical therapy

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult subjects age 19 or older with radiographically documented CRS

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685229

Contacts
Contact: England lenglan1@its.jnj.com

Locations
United States, Colorado
Associates of Otolaryngology Recruiting
Denver, Colorado, United States, 80210
United States, Florida
Tampa Bay ENT Cosmetic Surgery Recruiting
Brandon, Florida, United States, 33511
South Florida ENT Associates Recruiting
Miami, Florida, United States, 33176
United States, Georgia
ENT of Georgia Active, not recruiting
Atlanta, Georgia, United States, 30342
Georgia Nasal and Sinus Institute Recruiting
Savannah, Georgia, United States, 31404
Vidalia ENT Associates Recruiting
Vidalia, Georgia, United States, 30474
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611
Midwest Sinus Center Recruiting
Oak Brook, Illinois, United States, 60523
Rockford Health Physicians Recruiting
Rockford, Illinois, United States, 61114
United States, Indiana
Otorhinolaryngology Associates Recruiting
South Bend, Indiana, United States, 46635
United States, Kentucky
Advanced ENT & Allergy Recruiting
Louisville, Kentucky, United States, 40004
United States, New Jersey
Coastal Ear Nose and Throat Recruiting
Neptune Township, New Jersey, United States, 07753
United States, Ohio
Ohio Sinus Institute Recruiting
Dublin, Ohio, United States, 43016
United States, Texas
ENT Associates of Texas Recruiting
McKinney, Texas, United States, 75070
Collin County ENT Recruiting
Plano, Texas, United States, 75075
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Virginia Ear Nose and Throat Recruiting
Henrico, Virginia, United States, 23233
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Ear Nose Throat and Plastic Surgery Specialists Recruiting
Beaver Dam, Wisconsin, United States, 53916
Alliance ENT & Hearing Center Recruiting
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Spencer Payne, MD University of Virginia
Principal Investigator: Christopher Melroy, MD Georgia Nasal and Sinus Institute
Principal Investigator: Boris Karanfilov, MD Ohio Sinus Institute
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01685229     History of Changes
Other Study ID Numbers: CPR005028
Study First Received: September 12, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014