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

Integra LifeSciences

Status and phase: Completed; Phase 3

Conditions: Chronic Sinusitis

Treatments: Device: Sinuplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231062

CP-00313

Details and patient eligibility

About

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

Full 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, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.

The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Extensive sinonasal polyps
2. Extensive previous sinonasal surgery
3. Extensive sinonasal osteoneogenesis
4. Cystic fibrosis
5. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
8. Ciliary dysfunction
9. Pregnant females

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)