Phase 3
Completed N=115
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Chronic Sinusitis
Source: ClinicalTrials.gov NCT00231062 ↗
Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Number of Sinuses With Patency of Sinus Ostium After Sinuplasty — 247 Sinuses
Summary
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
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 | — |
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
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. Informational only — not medical advice.