CompletedPhase 3

Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

115 participantsStarted 2005-04

Plain-language summary

A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

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.

✓. Age 18 years and greater
✓. Both male and female patients eligible
✓. Diagnosis of chronic sinusitis that is not responsive to medical management
✓. Planned endoscopic sinus surgery (recommended by PI, consented to by patient)

✕. Extensive sinonasal polyps
✕. Extensive previous sinonasal surgery
✕. Extensive sinonasal osteoneogenesis
✕. Cystic fibrosis
✕. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
✕. Sinonasal tumors or obstructive lesions
✕. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
✕. Ciliary dysfunction

Number of Sinuses With Patency of Sinus Ostium After Sinuplasty

Timeframe: 24 weeks

Number of Participants With Adverse Events Following Sinuplasty Procedure

Timeframe: 24 weeks

NCT IDNCT00231062

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-06

Results submitted2011-04-29