CompletedPhase 2

Balloon REmodeling Antrostomy THErapy Study

United States71 participantsStarted 2007-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.
✓. Evidence of maxillary sinus air/liquid level.

What they're measuring

Incidences of Device-related or Procedure-related Complications

Timeframe: Through 12 months post-procedure

Patency of the Treated Area as Verified by CT Scan

Timeframe: Post-treatment at 3 months

Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement

Timeframe: Post-treatment through 12 months

Trial details

NCT IDNCT00645762

SponsorEntellus Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2013-03-15

View on ClinicalTrials.gov More Sinusitis trials