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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685229
First Posted: September 14, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acclarent
  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 ]

Secondary Outcome Measures:
  • Change in disease-specific patient-reported quality of life [ Time Frame: 12 and 52 weeks post treatment ]
  • Change in disease-specific and general health-related quality of life [ Time Frame: 12, 24 and 52 weeks post treatment ]
  • Change in disease-specific medication usage [ Time Frame: 12, 24 and 52 weeks post treatment ]
  • Missed days work/school and medical care visits due to sinusitis [ Time Frame: 12, 24 and 52 weeks post treatment ]
  • Number of sinus infections [ Time Frame: 24 and 52 weeks ]
  • Number of subjects requiring revision [ Time Frame: 52 weeks ]
  • Number of medical management subjects electing to cross-over to balloon sinus dilation procedure [ Time Frame: 52 weeks ]
  • Post-operative return to normal activity (RTNA) [ Time Frame: 2 weeks post treatment ]

Enrollment: 198
Study Start Date: September 2012
Study Completion Date: August 2015
Primary Completion Date: April 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01685229     History of Changes
Other Study ID Numbers: CPR005028
First Submitted: September 12, 2012
First Posted: September 14, 2012
Last Update Posted: October 12, 2017
Last Verified: August 2015

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