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

• Sponsor: Acclarent (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00231062
• Collaborator: (none)
• Enrollment: 115
• Duration (Months): 14

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinusitis	Device: Sinuplasty	Phase 3

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, 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 Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Number of Sinuses With Patency of Sinus Ostium After Sinuplasty [24 weeks]

   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.

2. Number of Participants With Adverse Events Following Sinuplasty Procedure [24 weeks]

   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).

Secondary Outcome Measures

1. Number of Participants Experiencing Relief of Sinus Symptoms [Week 24]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Acclarent

Investigators

• Principal Investigator: Christopher Church, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00231062
• Other Study ID Numbers: CP-00313
• First Posted: Oct 4, 2005
• Last Update Posted: Jul 8, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: sinusitis; rhinitis; sinus surgery; maxillary; ethmoid; sphenoid; frontal; FESS; sinuplasty
• Additional relevant MeSH terms: Sinusitis

Study Results

Participant Flow

Recruitment Details	Recruited from 3/2005 to 12/2005 in physician practice

Arm/Group Title	Balloon Dilation of Sinus Ostia
Arm/Group Description
Period Title: Overall Study
STARTED	115
COMPLETED	109
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Balloon Dilation of Sinus Ostia
Arm/Group Description
Overall Participants	115
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	102 88.7%
>=65 years	13 11.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (12.59)
Sex: Female, Male (Count of Participants)
Female	74 64.3%
Male	41 35.7%
Region of Enrollment (participants) [Number]
United States	115 100%

Outcome Measures

1. Primary Outcome

Title	Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
Description	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

Outcome Measure Data

Analysis Population Description

Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks

Arm/Group Title	Balloon Dilation of Sinus Ostia
Arm/Group Description
Measure Participants	95
Measure sinuses	304
Number [Sinuses]	247

2. Primary Outcome

Title	Number of Participants With Adverse Events Following Sinuplasty Procedure
Description	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

Outcome Measure Data

Analysis Population Description

Analysis per protocol; based on subjects not lost to follow-up at 24 weeks

Arm/Group Title	Balloon Dilation of Sinus Ostia
Arm/Group Description
Measure Participants	109
Number [Participants]	9 7.8%

3. Secondary Outcome

Title	Number of Participants Experiencing Relief of Sinus Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire

Arm/Group Title	Balloon Dilation of Sinus Ostia
Arm/Group Description
Measure Participants	95
Number [Participants]	80 69.6%

Adverse Events

Time Frame	6 months
Arm/Group Title	Balloon Dilation of Sinus Ostia
Arm/Group Description
All Cause Mortality
	Balloon Dilation of Sinus Ostia
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Balloon Dilation of Sinus Ostia
	Affected / at Risk (%)	# Events
Total	0/109 (0%)
Other (Not Including Serious) Adverse Events
	Balloon Dilation of Sinus Ostia
	Affected / at Risk (%)	# Events
Total	9/109 (8.3%)
General disorders
bacterial sinusitis	9/109 (8.3%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If requested by Sponsor, Investigator(s) shall delay the submission of any publication or presentation for up to sixty (60) days from the date of Sponsor's request to permit the preparation and filing of related patent applications by Sponsor or for Sponsor to take other steps to protect its intellectual property interests.