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Optimization and Refinement of Technique in In-Office Sinus Dilation 2

NCT01107379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 203

Last updated 2024-08-06

Study results available
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Summary

A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.

Conditions

  • Sinusitis

Interventions

DEVICE

Relieva Balloon Sinuplasty System

Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Michael Sillers, MD · Alabama Alabama Nasal and Sinus Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-01-31
Completion
2012-07-31

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 NCT01107379 on ClinicalTrials.gov