Balloon REmodeling Antrostomy THErapy
BREATHE I is a prospective, non-randomized, post-market, multi-center study designed to enroll a maximum of 100 subjects. In April 2008, the study device was cleared by the Food and Drug Administration (FDA) for commercial release. The objectives of the study are to evaluate the safety and effectiveness of the Entellus system in treating subjects with chronic rhinosinusitis (CRS) in the maxillary and anterior ethmoid sinuses. This study will also assess the feasibility of performing the Entellus procedure using local anesthesia only.
Primary efficacy endpoints:
- Change in post-treatment Sino-Nasal Outcomes Test-20 (SNOT- 20) scores at 1 week, 3 months, 6 months and 12 months
- Patency of the treated area (maxillary ostium and infundibular region) at 3-month follow-up via CT radiographic imaging
Primary safety endpoints:
- Incidence of device-related complications
- Incidence of procedure-related complications
FINDINGS
Entellus Medical presented two posters at the Combined Otolaryngology Scientific Meeting (COSM) in May 2008.
Early BREATHE I Results from a Novel System to Treat the Ethmoidal Infundibulum
BREATHE I Study Poster
Feasibility of endoscopic trans-antral maxillary sinus outflow tract balloon dilation
Proof of Concept Poster
CASE STUDY
A 24-year old female presented with symptoms at baseline consistent with chronic maxillary sinus disease including sinus headaches, purulent drainage, post-nasal discharge, nasal congestion, maxillary sinus pressure, and anosmia. In addition, prior to treatment the subject was treated with 7 rounds of antibiotic therapy over an 11-month period and also received 4 weeks of Augmentin XR immediately prior to baseline radiographic evaluation. The subject underwent unilateral balloon dilation on December 13, 2007.
The baseline CT (left image below) showed significant disease in the left maxillary sinus and obstruction of the infundibulum. The pre-operative SNOT-20 score was 3.8.
At the 3-months follow-up (right image below), radiological evaluation confirmed complete resolution of the mucosal thickening in the maxillary sinus and infundibulum. Symptomatic improvement was confirmed by a SNOT-20 score of 0.2 at 3 months and sustained through 6 months (SNOT-20 = 0.1).
For a list of physicians and study centers participating in the BREATHE I clinical trial, please click here: Balloon REmodeling Antrostomy THErapy Study - Full Text View - ClinicalTrials.gov.
For more information regarding participating in the study as either a principal investigator or as a clinical site, please contact the Entellus Medical Clinical Department at clinical@entellusmedical.com.