Trial Outcomes & Findings for Balloon REmodeling Antrostomy THErapy Study (NCT NCT00645762)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Through 12 months post-procedure

Results posted on

2013-07-29

Participant Flow

Enrolled patients with chronic rhinosinusitis (CRS) from Ear, Nose Throat (ENT) physician practices.

All patients had transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum with the FinESS Sinus System.

Participant milestones

Participant milestones
Measure	FinESS Sisnus System Balloon Dilation Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.
Overall Study STARTED	71
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Balloon REmodeling Antrostomy THErapy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Dilation n=71 Participants
Age Continuous	47.3 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants

PRIMARY outcome

Timeframe: Through 12 months post-procedure

Population: Patients completing 12 month follow-up

Outcome measures

Outcome measures
Measure	Treatment Group (ALL) n=67 Participants FinESS Balloon Dilation
Incidences of Device-related or Procedure-related Complications	1 participants 0.98

PRIMARY outcome

Timeframe: Post-treatment at 3 months

Population: Analysis of ostia patency done per protocol

Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.

Outcome measures

Outcome measures
Measure	Treatment Group (ALL) n=117 Treated Maxillary Ostia FinESS Balloon Dilation
Patency of the Treated Area as Verified by CT Scan	106 Ostia

PRIMARY outcome

Timeframe: Post-treatment through 12 months

Population: Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure.

Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.

Outcome measures

Outcome measures
Measure	Treatment Group (ALL) n=67 Participants FinESS Balloon Dilation
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement	-1.8 Scores on a scale

Adverse Events

Treatment Group (ALL)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group (ALL) n=71 participants at risk
Skin and subcutaneous tissue disorders Subcutaneous emphysema of the neck and upper chest	1.4% 1/71 • Number of events 1 • 12 months post-procedure

Other adverse events

Adverse event data not reported

Additional Information

Entellus Medical

Phone: 763-463-1599

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60