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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01685229
First received: September 12, 2012
Last updated: September 7, 2014
Last verified: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Colorado
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
Tampa Bay, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Savannah, Georgia, United States
Vidalia, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Rockford, Illinois, United States
United States, Indiana
South Bend, Indiana, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, New Jersey
Neptune Township, New Jersey, United States
United States, Ohio
Dublin, Ohio, United States
United States, Texas
Frisco, Texas, United States
McKinney, Texas, United States
Plano, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Wisconsin
Beaver Dam, Wisconsin, United States
Wauwatosa, Wisconsin, United States
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: September 7, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014