Trial Outcomes & Findings for Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up (NCT NCT01525849)

Last Updated: 2017-02-24

Results Overview

Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

Baseline and 1-year

Results posted on

2017-02-24

Participant Flow

Participants were screened, randomized, treated, and followed at 14 US centers from June 2011 to May 2014.

After screening, informed consent, and baseline measures, participants were randomized 1:1 to balloon sinus dilation or FESS. The assigned procedure was to be performed within 60 days of randomization.

Participant milestones

Participant milestones
Measure	Balloon Sinus Dilation Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Study STARTED	76	75
Overall Study Treated	74	61
Overall Study 6-Months	73	60
Overall Study COMPLETED	71	59
Overall Study NOT COMPLETED	5	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Balloon Sinus Dilation Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	1	9
Overall Study Unrelated medical issue (not treated)	1	2
Overall Study Anatomic exclusion criteria identified	0	3

Baseline Characteristics

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Sinus Dilation n=74 Participants Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=61 Participants Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.	Total n=135 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 13.6 • n=113 Participants	47.8 years STANDARD_DEVIATION 14.1 • n=163 Participants	46.9 years STANDARD_DEVIATION 13.8 • n=160 Participants
Gender Female	48 Participants n=113 Participants	36 Participants n=163 Participants	84 Participants n=160 Participants
Gender Male	26 Participants n=113 Participants	25 Participants n=163 Participants	51 Participants n=160 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=113 Participants	5 Participants n=163 Participants	11 Participants n=160 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=113 Participants	56 Participants n=163 Participants	124 Participants n=160 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	4 Participants n=113 Participants	1 Participants n=163 Participants	5 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	2 Participants n=113 Participants	4 Participants n=163 Participants	6 Participants n=160 Participants
Race (NIH/OMB) White	65 Participants n=113 Participants	56 Participants n=163 Participants	121 Participants n=160 Participants
Race (NIH/OMB) More than one race	3 Participants n=113 Participants	0 Participants n=163 Participants	3 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment United States	74 participants n=113 Participants	61 participants n=163 Participants	135 participants n=160 Participants
Sino-Nasal Outcome Test (SNOT-20) overall score	2.49 units on a scale STANDARD_DEVIATION 0.88 • n=113 Participants	2.52 units on a scale STANDARD_DEVIATION 0.83 • n=163 Participants	2.50 units on a scale STANDARD_DEVIATION 0.85 • n=160 Participants

PRIMARY outcome

Timeframe: Baseline and 1-year

Population: All treated participants with matched pair SNOT-20 data at baseline and 1-year.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=69 Participants Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=58 Participants Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Sinus Symptom Improvement Change from baseline	-1.59 units on a scale Standard Deviation 1.08	-1.60 units on a scale Standard Deviation 1.00
Sinus Symptom Improvement Mean overall SNOT-20 score at 1-year	0.88 units on a scale Standard Deviation 0.91	0.88 units on a scale Standard Deviation 0.76

PRIMARY outcome

Timeframe: 1-year

Population: All treated participants

Number of postoperative debridements per participant

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=74 Participants Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=61 Participants Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Debridements	0.23 debridements per participant Standard Deviation 0.65	1.03 debridements per participant Standard Deviation 0.87

SECONDARY outcome

Timeframe: 1-year

Population: All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up).

Number of participants requiring repeat sinus procedures

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=71 Participants Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=59 Participants Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Revision Rate	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Duration of study (minimum of 12 months)

Population: All randomized participants

Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=76 Participants Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=75 Participants Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Complication Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6-months

Population: All treated participants with 6-month follow-up.

Mean time (days) after procedure for participants to return to normal activities

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=73 Participants Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=60 Participants Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Recovery Time	1.7 days Standard Deviation 1.3	5.0 days Standard Deviation 5.9

Adverse Events

Balloon Sinus Dilation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Functional Endoscopic Sinus Surgery

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Balloon Sinus Dilation n=76 participants at risk Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment	Functional Endoscopic Sinus Surgery n=75 participants at risk Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Gastrointestinal disorders Acute Gastroenteritis	1.3% 1/76 • Number of events 1 • Duration of study (minimum of 1-year) for all treated participants. Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.	0.00% 0/75 • Duration of study (minimum of 1-year) for all treated participants. Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.
Cardiac disorders Atypical Chest Pain	0.00% 0/76 • Duration of study (minimum of 1-year) for all treated participants. Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.	1.3% 1/75 • Number of events 1 • Duration of study (minimum of 1-year) for all treated participants. Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.
Infections and infestations Infection	0.00% 0/76 • Duration of study (minimum of 1-year) for all treated participants. Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.	1.3% 1/75 • Number of events 1 • Duration of study (minimum of 1-year) for all treated participants. Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.

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