Trial Outcomes & Findings for Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study (NCT NCT01612780)

Results Overview

The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

Baseline and 1-year post procedure

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Sinus Dilation Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Overall Study STARTED	82
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Balloon Sinus Dilation Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Overall Study Treatment not completed	1
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Sinus Dilation n=82 Participants Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Age, Continuous	50.1 years STANDARD_DEVIATION 16.7 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	82 Participants n=5 Participants
Type of sinusitis Chronic rhinosinusitis	73 Participants n=5 Participants
Type of sinusitis Recurrent acute rhinosinusitis	9 Participants n=5 Participants
Baseline SNOT-20 score	2.27 units on a scale STANDARD_DEVIATION 0.92 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1-year post procedure

Population: All participants who had 1 or more sinuses successfully treated with the XprESS device and both baseline and 1-year follow-up SNOT-20 scores available for analysis.

The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=75 Participants Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Change in SNOT-20 Score Baseline	2.3 score on a scale Standard Deviation 0.92
Change in SNOT-20 Score 1-Year follow-up	0.7 score on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: 1-year post procedure

Population: All participants with 1 or more sinuses successfully treated with the XprESS device.

The number of participants who require revision sinus surgery to address continuing sinus symptoms.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=81 Participants Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Revision Sinus Surgery	1 Participants

SECONDARY outcome

Timeframe: Through 1-year post procedure follow-up

Population: All enrolled participants.

Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=82 Participants Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Number of Participants With Serious Device and/or Procedure-related Adverse Events	0 Participants

Adverse Events

Balloon Sinus Dilation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Balloon Sinus Dilation n=82 participants at risk Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Infections and infestations Tick-borne illness	1.2% 1/82 • Number of events 1 • Adverse events were systematically collected by standardized case report forms through 1 year post procedure. All SAEs, regardless of relationship to the study device and/or procedure, were reported. The protocol only required nonserious AEs that were classified by the Investigator as device-related and/or procedure-related to be collected.

Other adverse events

Adverse event data not reported

Additional Information

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60