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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sinuplasty

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No