Trial Outcomes & Findings for Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (NCT NCT00939471)

Results Overview

Number of device-related adverse events from time of procedure through 12 months post-procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

12 months

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Device Balloon catheter dilation of sinus ostia
Overall Study STARTED	44
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Device n=44 Participants Balloon catheter dilation of sinus ostia
Age, Categorical <=18 years	44 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	8.14 years STANDARD_DEVIATION 3.99 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of device-related adverse events from time of procedure through 12 months post-procedure.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=44 Participants Balloon catheter dilation of sinus ostia
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months	0 number of events

PRIMARY outcome

Timeframe: 12 months

Population: Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).

Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=23 Participants Balloon catheter dilation of sinus ostia
Effectiveness: Change in Sinus Symptom Scores (SN-5)	2.00 change in SN-5 score Standard Deviation 1.40

PRIMARY outcome

Timeframe: 12 months

Population: Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).

Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=7 Participants Balloon catheter dilation of sinus ostia
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)	0.95 change in SNOT-20 score Standard Deviation 0.51

SECONDARY outcome

Timeframe: 12 months

Population: intent to treat analysis

Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=88 sinuses Balloon catheter dilation of sinus ostia
Device Success: Ability to Access/Dilate Sinus Ostia	90.9 percentage of sinuses successful

SECONDARY outcome

Timeframe: 12 months

Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=41 Participants Balloon catheter dilation of sinus ostia
Effectiveness: Medication Thru 1 yr	68.3 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=44 Participants Balloon catheter dilation of sinus ostia
Effectiveness of Dilation/Measured by Post-op Interventions	0 number of interventions

SECONDARY outcome

Timeframe: 12 months

Quantitative assessment of days out of school during the 12 months of follow-up.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=24 Participants Balloon catheter dilation of sinus ostia
Days Out of School During the 12 Months of Follow-up	5.75 days Standard Deviation 7.46

SECONDARY outcome

Timeframe: at 1 year

The number of subjects requiring revisions out of 33 subjects treated.

Outcome measures

Outcome measures
Measure	Balloon Sinuplasty Treatment n=33 Participants Balloon catheter dilation of sinus ostia
Revision Rate	2 participants

Adverse Events

Balloon Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura England, Manager-Clinical

Acclarent, Inc.

Phone: 650-687-4466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Scientific Publications Reporting results initiated only by SPONSOR. Sites may not publish single center results before aggregate results. Drafts of abstracts, etc. must be submitted to SPONSOR for review at least sixty (60) days prior to submission for publication. Investigator(s) shall delay submission for up to 90 days to permit patent application filing or shall redact paper to remove language detrimental to SPONSOR's intellectual property interests.
Publication restrictions are in place

Restriction type: OTHER