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Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

NCT01685229 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2024-07-12

Study results available
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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.

Conditions

  • Sinusitis

Interventions

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.

DRUG

Medical Management

Subjects who select to continue on medical management rather than have a BSD procedure.

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Spencer Payne, MD · University of Virginia

  • Christopher Melroy, MD · Georgia Nasal and Sinus Institute

  • Boris Karanfilov, MD · Ohio Sinus Institute

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-01
Primary Completion
2015-04-01
Completion
2015-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01685229 on ClinicalTrials.gov