SinusitisMERLOTNCT01685229
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
An observational study of Sinusitis, run by Integra LifeSciences Corporation at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Balloon sinus dilation and Medical Management
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Sep 2012to 1 Aug 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects age 19 or older with radiographically documented CRS
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Atlanta, Georgia
Study site
Beaver Dam, Wisconsin
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Denver, Colorado
Study site
Dublin, Ohio
Study site
Frisco, Texas
Study site
Louisville, Kentucky
Study site
McKinney, Texas
Study site
Miami, Florida
Study site
Neptune City, New Jersey
Study site
Norfolk, Virginia
Study site
Plano, Texas
Study site
Richmond, Virginia
Study site
Rockford, Illinois
Study site
Savannah, Georgia
Study site
South Bend, Indiana
Study site
Tampa, Florida
Study site
Vidalia, Georgia
Study site
Wauwatosa, Wisconsin
About this study
Official title: Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
- Conditions
- Sinusitis
- Being tested
- Balloon sinus dilation, Medical Management
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon sinus dilationDevice
Also called Acclarent Balloon Sinuplasty System
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.
Medical ManagementDrug
Subjects who select to continue on medical management rather than have a BSD procedure.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Sinus Dilation | Subjects with chronic sinusitis electing to have a balloon sinus dilation Receives: Device: Balloon sinus dilation | |
| Medical Management | Subjects with chronic sinusitis electing to continue with medical therapy Receives: Drug: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline
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.
Measured: 24 weeks post treatment
Secondary outcomes (10)
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline
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.
Measured: 12, 24, and 52 weeks post treatment
Change in RSDI
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).
Measured: 12, 24 and 52 weeks post treatment
Change in SNOT-20
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.
Measured: 12 weeks, 24 weeks, 52 weeks post treatment
Change in Disease-specific Medication Usage
Measured: 12, 24 and 52 weeks post treatment
Missed Days Work/School
Measured: 12, 24 and 52 weeks post treatment
Number of Sinus-related Medical Care Visits
Measured: 12 weeks, 24 weeks, 52 weeks post treatment
Number of Sinus Infections
Measured: 24 and 52 weeks
Number of Subjects Requiring Revision for Subjects Electing BSD
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.
Measured: 52 weeks
Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure
Measured: 52 weeks
Post-operative Return to Normal Activity (RTNA)
Measured: 2 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start1 Sep 2012
- Primary completion1 Apr 2015
- Study completion1 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Spencer Payne, MD, Principal investigator, University of VirginiaChristopher Melroy, MD, Principal investigator, Georgia Nasal and Sinus InstituteBoris Karanfilov, MD, Principal investigator, Ohio Sinus Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685229
- Sponsor's protocol ID
- CPR005028
- Acronym
- MERLOT
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2012
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication is planned
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)
- ClinicalTrials.gov ID
- NCT01685229
- Acronym / sponsor ID
- MERLOT / CPR005028
- Conditions
- Sinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Aug 2015 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Posted 13 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Sinus Dilation | – | Device: Balloon sinus dilationSubjects with chronic sinusitis electing to have a balloon sinus dilation |
| Medical Management | – | Drug: Medical ManagementSubjects with chronic sinusitis electing to continue with medical therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects age 19 or older with radiographically documented CRS
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon sinus dilationAlso: Acclarent Balloon Sinuplasty SystemSubjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention. | Device | Balloon Sinus Dilation |
| Medical ManagementSubjects who select to continue on medical management rather than have a BSD procedure. | Drug | Medical Management |
Primary outcome
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.
10 secondary outcomes
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
Change in RSDI
Time frame: 12, 24 and 52 weeks post treatment
Change in SNOT-20
Time frame: 12 weeks, 24 weeks, 52 weeks post treatment
Change in Disease-specific Medication Usage
Time frame: 12, 24 and 52 weeks post treatment
Missed Days Work/School
Time frame: 12, 24 and 52 weeks post treatment
Number of Sinus-related Medical Care Visits
Time frame: 12 weeks, 24 weeks, 52 weeks post treatment
Number of Sinus Infections
Time frame: 24 and 52 weeks
Number of Subjects Requiring Revision for Subjects Electing BSD
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Publication is planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spencer Payne, MD principal investigator
University of Virginia
Christopher Melroy, MD principal investigator
Georgia Nasal and Sinus Institute
Boris Karanfilov, MD principal investigator
Ohio Sinus Institute
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by Integra LifeSciences Corporation at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline (time frame: 24 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.