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

Integra LifeSciences Corporation115 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Chronic Sinusitis

Interventions

SinuplastyDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Sinuses With Patency of Sinus Ostium After Sinuplasty

Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.

Time frame: 24 weeks

Number of Participants With Adverse Events Following Sinuplasty Procedure

Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).

Time frame: 24 weeks

Secondary Outcomes

Number of Participants Experiencing Relief of Sinus Symptoms

To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.

Time frame: Week 24

Data from ClinicalTrials.gov

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