Trial Outcomes & Findings for Balloon Sinus Dilation In Office or OR (NCT NCT00939393)

NCT ID: NCT00939393

Last Updated: 2024-07-12

Results Overview

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2024-07-12

Participant Flow

Eligible patients presenting to the study sites (medical clinics) for whom endoscopic sinus surgery was recommended were offered the opportunity to participate in the study by study investigators.

Participant milestones

Measure	In Office Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Overall Study STARTED	37	35
Overall Study COMPLETED	33	35
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	In Office Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Balloon Sinus Dilation In Office or OR

Baseline characteristics by cohort

Measure	Office n=37 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=35 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.	Total n=72 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 12.5 • n=5 Participants	47.5 years STANDARD_DEVIATION 15.1 • n=7 Participants	51.2 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	35 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure.

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

Outcome measures

Measure	In Office n=26 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=25 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline	-1.25 scores on a scale Standard Deviation 0.99	-1.35 scores on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 24 weeks

Population: Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure.

The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.

Outcome measures

Measure	In Office n=29 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=20 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]	-3.83 Scores on a scale Standard Deviation 4.08	-5.65 Scores on a scale Standard Deviation 5.27

SECONDARY outcome

Timeframe: Day 0

Population: Eight (8) In-Office subjects were missing data for this outcome measure.

Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.

Outcome measures

Measure	In Office n=29 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Proportion of Participants Rating Procedure as Tolerable (IO Only)	27 participants	—

SECONDARY outcome

Timeframe: Day 0

Population: One (1) In-Office subject was missing data for this outcome measure.

Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.

Outcome measures

Measure	In Office n=36 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)	24 participants	—

SECONDARY outcome

Timeframe: 52 weeks

A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.

Outcome measures

Measure	In Office n=37 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Mean Number of Debridements Per Participant (IO Only)	0.42 debridements Standard Deviation 0.51	—

SECONDARY outcome

Timeframe: 52 weeks

After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.

Outcome measures

Measure	In Office n=37 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Proportion of Participants With Revisions (IO Only)	1 participants	—

SECONDARY outcome

Timeframe: 52 weeks

Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).

Outcome measures

Measure	In Office n=37 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=35 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Proportion of Participants With Post-operative Sinus Infections	13 participants	12 participants

SECONDARY outcome

Timeframe: 1 week

Population: Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

Outcome measures

Measure	In Office n=32 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=33 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline	-0.98 scores on a scale Standard Deviation 0.79	-0.71 scores on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 4 weeks

Population: Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

Outcome measures

Measure	In Office n=31 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=33 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline	-1.32 scores on a scale Standard Deviation 0.89	-1.21 scores on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 52 weeks

Population: Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure.

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

Outcome measures

Measure	In Office n=21 Participants Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=11 Participants Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline	-1.43 scores on a scale Standard Deviation 0.96	-1.10 scores on a scale Standard Deviation 1.05

Adverse Events

Office

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Operating Room

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Office n=37 participants at risk Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.	Operating Room n=35 participants at risk Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/37 • 1 year Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.	2.9% 1/35 • Number of events 1 • 1 year Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.
Gastrointestinal disorders Swallowed pledget	2.7% 1/37 • Number of events 1 • 1 year Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.	0.00% 0/35 • 1 year Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.

Additional Information

Clinical Director

Acclarent, Inc.

Phone: 650-687-5888

Email: lenglan1@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60