Completed
MERLOTMedical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)
What is being collected
Device Data
+ drug Data
Collected from today forward - ProspectiveDeviceDrug
Who is being recruted
Infections+4
+ Nose Diseases
+ Otorhinolaryngologic Diseases
Over 19 Years
+12 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: September 2012
Summary
Principal SponsorIntegra LifeSciences Corporation
Last updated: July 12, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
Principal SponsorIntegra LifeSciences Corporation
Last updated: July 12, 2024
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
198 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 19 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
InfectionsNose DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsSinusitis
Criteria
7 inclusion criteria required to participate
Able to read and understand English
Diagnosis of Chronic Rhinosinusitis (CRS)
Failure of appropriate medical management
Males and females aged 19 or greater
Show More Criteria
5 exclusion criteria prevent from participating
Clinically significant illness that may interfere with the evaluation of the study
Not suitable for balloon dilation for all peripheral sinuses that require treatment
Patients involved in other clinical studies 30 days prior to study
Patients unable to adhere to follow-up schedule or protocol requirements
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 20 locations
Denver, United StatesOpen in Google Maps
Miami, United States
Tampa, United States
Atlanta, United States
Completed20 Study Centers