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Trial Outcomes & Findings for XprESS Maxillary Balloon Dilation Study (NCT NCT01525862)

NCT ID: NCT01525862

Last Updated: 2020-11-10

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

21 participants

Primary outcome timeframe

Baseline and 6 months post procedure

Results posted on

2020-11-10

Participant Flow

Participant milestones

Participant milestones
Measure
Balloon Sinus Dilation
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
Overall Study
STARTED
21
Overall Study
COMPLETED
21
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

XprESS Maxillary Balloon Dilation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Balloon Sinus Dilation
n=21 Participants
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
Age, Continuous
52 years
STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Region of Enrollment
United States
21 participants
n=5 Participants
Lund-Mackay score
4.7 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
Smoking status
Nonsmokers
19 Participants
n=5 Participants
Smoking status
Smokers
2 Participants
n=5 Participants
Allergies (year-round or seasonal)
16 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months post procedure

Population: All participants with baseline and 6-month follow-up SNOT-20 assessments (matched pairs).

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=21 Participants
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
SNOT-20 Score
Baseline
2.3 score on a scale
Standard Deviation 0.8
SNOT-20 Score
6-Month Follow-up
0.8 score on a scale
Standard Deviation 0.6

SECONDARY outcome

Timeframe: 1 week post procedure

Patient-reported time from procedure to ability to return to normal daily activities.

Outcome measures

Outcome measures
Measure
Balloon Sinus Dilation
n=21 Participants
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
Recovery Time
16.1 hours
Standard Deviation 17.8

SECONDARY outcome

Timeframe: Immediately post procedure

Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.

Outcome measures

Outcome measures
Measure
Balloon Sinus Dilation
n=21 Participants
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
Procedural Pain Scores
1.8 score on a scale
Standard Deviation 1.8

SECONDARY outcome

Timeframe: 6 Months post procedure

The number of participants who require revision sinus surgery during the study duration.

Outcome measures

Outcome measures
Measure
Balloon Sinus Dilation
n=21 Participants
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
Revision Rate
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=21 participants at risk
Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation
Endocrine disorders
Complication of diabetes mellitus
4.8%
1/21 • Number of events 1 • 6 months post procedure

Other adverse events

Adverse event data not reported

Additional Information

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 764-463-1598

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60