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Trial record 2 of 6 for:    merlot

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

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.
 
ClinicalTrials.gov Identifier: NCT01685229
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Acclarent

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.

Condition or disease Intervention/treatment
Sinusitis Device: Balloon sinus dilation Drug: Medical Management

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Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : April 1, 2015
Actual Study Completion Date : August 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Group/Cohort Intervention/treatment
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
Drug: Medical Management
Subjects who select to continue on medical management rather than have a BSD procedure.




Primary Outcome Measures :
  1. Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline [ Time Frame: 24 weeks post treatment ]

    The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.

    The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best).

    The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.

    Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).

    Higher score indicates greater improvement.



Secondary Outcome Measures :
  1. Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline [ Time Frame: 12, 24, and 52 weeks post treatment ]
    The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom‐based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication‐based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks"), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.

  2. Change in RSDI [ Time Frame: 12, 24 and 52 weeks post treatment ]

    The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 ("Never") to 4 ("Always") and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.

    The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).


  3. Change in SNOT-20 [ Time Frame: 12 weeks, 24 weeks, 52 weeks post treatment ]

    The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.

    Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).

    Lower score indicates greater improvement.


  4. Change in Disease-specific Medication Usage [ Time Frame: 12, 24 and 52 weeks post treatment ]
  5. Missed Days Work/School [ Time Frame: 12, 24 and 52 weeks post treatment ]
  6. Number of Sinus-related Medical Care Visits [ Time Frame: 12 weeks, 24 weeks, 52 weeks post treatment ]
  7. Number of Sinus Infections [ Time Frame: 24 and 52 weeks ]
  8. Number of Subjects Requiring Revision for Subjects Electing BSD [ Time Frame: 52 weeks ]
    A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.

  9. Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure [ Time Frame: 52 weeks ]
  10. Post-operative Return to Normal Activity (RTNA) [ Time Frame: 2 weeks post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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

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
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United States, Colorado
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
Tampa, 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, 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
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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

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Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01685229    
Other Study ID Numbers: CPR005028
First Posted: September 14, 2012    Key Record Dates
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication is planned
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases