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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231062
• Other study ID #: CP-00313
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: June 10, 2011
• Start date: April 2005
• Est. completion date: June 2006

Study information

• Verified date: June 2011
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• Sinuplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks	No
Primary	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).	24 weeks	Yes
Secondary	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.	Week 24	No