CompletedNot Applicable

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

United States151 participantsStarted 2011-12

Plain-language summary

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years or older * maxillary sinus disease * chronic sinusitis Exclusion Criteria: * fungal disease * Samter's triad * hemophilia * prior sinus surgery

What they're measuring

Sinus Symptom Improvement

Timeframe: Baseline and 1-year

Debridements

Timeframe: 1-year

Trial details

NCT IDNCT01525849

SponsorEntellus Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2016-11-01

View on ClinicalTrials.gov More Chronic Sinusitis trials