Status:
COMPLETED
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
Detailed Description
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, los...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00231062
Start Date
April 1 2005
End Date
June 1 2006
Last Update
August 6 2024
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