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

Integra LifeSciences

Status: Completed

Conditions: Sinusitis

Treatments: Drug: Medical Management; Device: Balloon sinus dilation

Study type: Observational

Funder types: Industry

Identifiers

NCT01685229

CPR005028

Details and patient eligibility

About

This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.

Enrollment: 198 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

198 participants in 2 patient groups

Balloon Sinus Dilation

Description:

Subjects with chronic sinusitis electing to have a balloon sinus dilation

Treatment:

Device: Balloon sinus dilation

Medical Management

Description:

Subjects with chronic sinusitis electing to continue with medical therapy

Treatment:

Drug: Medical Management