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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 Oct 22, 2026, 12:42 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.

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

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
Sep 2007 (Type not available)
Primary completion
Jun 2010 (Actual)
Completion
Jun 2010 (Actual)
Last update posted
Jul 29, 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 29, 2013 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00645762 live on ClinicalTrials.gov.

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