Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:19 - Any
Updated:10/14/2017
Start Date:September 2012
End Date:August 2015

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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.


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
We found this trial at
20
sites
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mi
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Dublin, OH
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Atlanta, GA
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from
Beaver Dam, WI
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from
Charlottesville, VA
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from
Chicago, IL
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from
Denver, CO
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from
Frisco, TX
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from
Louisville, KY
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from
McKinney, TX
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from
Miami, FL
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from
Neptune Township, NJ
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from
Norfolk, VA
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from
Plano, TX
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from
Richmond, VA
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from
Rockford, IL
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from
Savannah, GA
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from
South Bend, IN
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from
Tampa Bay, FL
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from
Vidalia, GA
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mi
from
Wauwatosa, WI
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