Trial Outcomes & Findings for Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) (NCT NCT00231062)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

115 participants

Primary outcome timeframe

24 weeks

Results posted on

2024-08-06

Participant Flow

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

Participant milestones

Participant milestones
Measure	Balloon Dilation of Sinus Ostia
Overall Study STARTED	115
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Balloon Dilation of Sinus Ostia
Overall Study Physician Decision	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Dilation of Sinus Ostia n=115 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	102 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 12.59 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	115 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 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.

Outcome measures

Outcome measures
Measure	Balloon Dilation of Sinus Ostia n=304 sinuses
Number of Sinuses With Patency of Sinus Ostium After Sinuplasty	247 Sinuses

PRIMARY outcome

Timeframe: 24 weeks

Population: Analysis per protocol; based on subjects not lost to follow-up at 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).

Outcome measures

Outcome measures
Measure	Balloon Dilation of Sinus Ostia n=109 Participants
Number of Participants With Adverse Events Following Sinuplasty Procedure	9 Participants

SECONDARY outcome

Timeframe: Week 24

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

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.

Outcome measures

Outcome measures
Measure	Balloon Dilation of Sinus Ostia n=95 Participants
Number of Participants Experiencing Relief of Sinus Symptoms	80 Participants

Adverse Events

Balloon Dilation of Sinus Ostia

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Balloon Dilation of Sinus Ostia n=109 participants at risk
General disorders bacterial sinusitis	8.3% 9/109 • Number of events 9 • 6 months

Additional Information

Laura England, Manager-Clinical Affairs

Acclarent

Phone: 650-687-4466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER