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Trial Outcomes & Findings for XprESS Registry Study (NCT NCT01115309)

NCT ID: NCT01115309

Last Updated: 2020-10-27

Results Overview

Adverse event reporting as related to XprESS device or procedure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

1 month after procedure

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure
XprESS Balloon Device
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Procedure Safety (1-Month)
STARTED
175
Procedure Safety (1-Month)
COMPLETED
172
Procedure Safety (1-Month)
NOT COMPLETED
3
Long-term Follow-up
STARTED
50
Long-term Follow-up
6-Month Follow-up
46
Long-term Follow-up
12-Month Follow-up
44
Long-term Follow-up
COMPLETED
44
Long-term Follow-up
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
XprESS Balloon Device
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Procedure Safety (1-Month)
Lost to Follow-up
2
Procedure Safety (1-Month)
Withdrawal by Subject
1
Long-term Follow-up
Lost to Follow-up
6

Baseline Characteristics

Lund-Mackay is provided for those participants who had a preoperative scan available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
XprESS Balloon Device
n=175 Participants
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Age, Continuous
50.8 years
STANDARD_DEVIATION 16.4 • n=175 Participants
Sex: Female, Male
Female
78 Participants
n=175 Participants
Sex: Female, Male
Male
97 Participants
n=175 Participants
Region of Enrollment
United States
175 participants
n=175 Participants
Lund-Mackay score
6.9 units on a scale
STANDARD_DEVIATION 4.6 • n=86 Participants • Lund-Mackay is provided for those participants who had a preoperative scan available.
SNOT-20
2.1 units on a scale
STANDARD_DEVIATION 1.0 • n=170 Participants • Baseline SNOT-20 assessments were inadvertently lost for 5 participants.
Nasal polyps
55 Participants
n=175 Participants
Area of sinusitis
Maxillary
162 Participants
n=175 Participants
Area of sinusitis
Anterior ethmoid
133 Participants
n=175 Participants
Area of sinusitis
Posterior ethmoid
116 Participants
n=175 Participants
Area of sinusitis
Frontal
145 Participants
n=175 Participants
Area of sinusitis
Sphenoid
106 Participants
n=175 Participants

PRIMARY outcome

Timeframe: 1 month after procedure

Population: All enrolled participants.

Adverse event reporting as related to XprESS device or procedure

Outcome measures

Outcome measures
Measure
XprESS Balloon Device
n=175 Participants
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Safety Assessments
2 Participants

SECONDARY outcome

Timeframe: Baseline and 1 month after procedure

Population: All participants with baseline and 1-month SNOT-20 scores.

The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.

Outcome measures

Outcome measures
Measure
XprESS Balloon Device
n=170 Participants
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
Baseline
2.1 score on a scale
Standard Deviation 1.0
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
1-Month Follow-up
1.0 score on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline and 6 months post procedure

Population: Participants enrolled in the long-term follow-up who have matching baseline and 6-month SNOT-20 scores.

The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.

Outcome measures

Outcome measures
Measure
XprESS Balloon Device
n=46 Participants
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
SNOT-20 at 6 Months
Baseline
2.0 score on a scale
Standard Deviation 1.1
SNOT-20 at 6 Months
6-Month Follow-up
0.8 score on a scale
Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: Participants who were enrolled in the long-term follow-up and have matching baseline and 12-month SNOT-20 scores.

The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.

Outcome measures

Outcome measures
Measure
XprESS Balloon Device
n=44 Participants
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
SNOT-20 at 12 Months
Baseline
1.9 score on a scale
Standard Deviation 1.1
SNOT-20 at 12 Months
12-Month Follow-up
0.8 score on a scale
Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Population: Frontal and sphenoid sinuses treated with XprESS and evaluated by endoscopy or CT scan at 12 months post procedure.

Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study.

Outcome measures

Outcome measures
Measure
XprESS Balloon Device
n=83 Sinuses
XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Number of Sinuses Demonstrating Functional Patency
76 Sinuses

Adverse Events

XprESS Balloon Device

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

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Results disclosure agreements

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

Restriction type: LTE60