Trial Outcomes & Findings for Sinus Balloon Dilation in Pediatric Patients (NCT NCT02278484)

Results Overview

Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Index procedure

Results posted on

2017-04-11

Participant Flow

Sequential enrollment of eligible participants at sites.

Participant milestones

Participant milestones
Measure	Balloon Sinus Dilation Balloon Sinus Dilation using XprESS and PathAssist Devices.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sinus Balloon Dilation in Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Sinus Dilation n=50 Participants Balloon Sinus Dilation using XprESS and PathAssist Devices.
Age, Continuous	9.7 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Index procedure

Population: All sinus dilations attempted in all participants

Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=157 Sinuses Balloon Sinus Dilation Using XprESS and PathAssist Devices.
Technical Success: Sinuses Successfully Treated With Balloon Dilation	157 sinus dilation attempts

PRIMARY outcome

Timeframe: Index procedure through 3-month follow-up

Population: All participants

Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=50 Participants Balloon Sinus Dilation Using XprESS and PathAssist Devices.
Complications	0 participants

SECONDARY outcome

Timeframe: Baseline to 6-month follow-up

Population: All participants

Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=50 Participants Balloon Sinus Dilation Using XprESS and PathAssist Devices.
Change in Quality of Life From Baseline Through Completion	-2.9 Units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Procedure-6 month follow up

Population: All participants

Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=50 Participants Balloon Sinus Dilation Using XprESS and PathAssist Devices.
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study	0 Participants

Adverse Events

Balloon Sinus Dilation

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

Ellen O'Malley

Entellus Medical

Phone: 763-463-1598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60