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Completed Phase 2 Interventional Results available

Balloon REmodeling Antrostomy THErapy Study

ClinicalTrials.gov ID: NCT00645762

Public ClinicalTrials.gov record NCT00645762. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Study identification

NCT ID
NCT00645762
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Entellus Medical, Inc.
Industry
Enrollment
71 participants

Conditions and interventions

Conditions

Interventions

  • RS-Series Rhinosinusitis Treatment System Device
  • FinESS Balloon Device

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2007
Primary completion
May 31, 2010
Completion
May 31, 2010
Last update posted
Jul 28, 2013

2007 – 2010

United States locations

U.S. sites
13
U.S. states
9
U.S. cities
13
Facility City State ZIP Site status
Central California Ear, Nose and Throat Medical Group Fresno California 93720
NorthShore University HealthSystem Evanston Illinois 60201
Loyola University Medical Center Maywood Illinois 60153
St. Cloud Ear, Nose & Throat - Head and Neck Clinic Saint Cloud Minnesota 56303
Otolaryngology-Facial Plastic Surgery of Long Island P.C. Lake Success New York 11042
Charlotte Eye, Ear, Nose & Throat Associates Charlotte North Carolina 28210
Midwest Ear, Nose, and Throat Sioux Falls South Dakota 57108
Holston Medical Group Kingsport Tennessee 37660
Vanderbilt University Medical Center Nashville Tennessee 37232
Austin Ear, Nose & Throat Clinic Austin Texas 78705-1023
Texas Sinus Center Boerne Texas 78006
San Antonio Ear, Nose, and Throat Research San Antonio Texas 78229
Ear, Nose, Throat & Plastic Surgery Associates, PS Auburn Washington 98002

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00645762, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 28, 2013 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00645762 live on ClinicalTrials.gov.

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