Phase 3 N=115 Treatment

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

Chronic Sinusitis

Bottom Line

View on ClinicalTrials.gov: NCT00231062 ↗

Enrolled (actual)

115

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Number of Sinuses With Patency of Sinus Ostium After Sinuplasty — 247 Sinuses

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sinuplasty (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Integra LifeSciences Corporation
Primary completion: Jun 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Sinuses With Patency of Sinus Ostium After Sinuplasty	247	—
PRIMARY Number of Participants With Adverse Events Following Sinuplasty Procedure	9	—
SECONDARY Number of Participants Experiencing Relief of Sinus Symptoms	80	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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
Pregnant females

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00231062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.