Trial Outcomes & Findings for Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (NCT NCT01107379)

Results Overview

Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. 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 and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the 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

Target enrollment

203 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2024-08-06

Participant Flow

The lead-in cohort (N=36) consisted of each investigator's first cases where all targeted sinuses were successfully dilated (minimum of 3 cases) with the exception of 4 investigators who participated in the prior ORIOS study.

Participant milestones

Participant milestones
Measure	Balloon Device Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Overall Study STARTED	203
Overall Study COMPLETED	182
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Balloon Device Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Overall Study Withdrawal by Subject	18
Overall Study Lost to Follow-up	3

Baseline Characteristics

Optimization and Refinement of Technique in In-Office Sinus Dilation 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Catheter Device n=203 Participants Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation
Age, Continuous	48.6 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	22 participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	145 participants n=5 Participants
Race/Ethnicity, Customized Asian	5 participants n=5 Participants
Race/Ethnicity, Customized Black or African	22 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian / Other Pacific Islander	1 participants n=5 Participants
Race/Ethnicity, Customized North American Indian or Inuit	2 participants n=5 Participants
Race/Ethnicity, Customized Other (not specified)	6 participants n=5 Participants
Region of Enrollment United States	203 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.

Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. 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 and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the 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

Outcome measures
Measure	Balloon Device n=113 Participants Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Mean Intra-patient Change in SNOT-20 Score	-1.16 Scores on a scale Standard Deviation 1.03

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.

Change in Lund-Mackay CT score for paired baseline and 24 week data. 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

Outcome measures
Measure	Balloon Device n=111 Participants Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Mean Intra-patient Change in Lund-Mackay CT Scan Score	-4.32 Scores on a scale Standard Deviation 3.56

SECONDARY outcome

Timeframe: Day 0 (Day of Procedure)

Population: Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.

Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.

Outcome measures

Outcome measures
Measure	Balloon Device n=198 Participants Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Procedure Tolerability	163 number of participants Interval 76.3 to 87.4

SECONDARY outcome

Timeframe: Day 0 (Day of Procedure)

Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary

Outcome measures

Outcome measures
Measure	Balloon Device n=592 sinuses Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary	552 number of sinuses Interval 90.91 to 95.13

SECONDARY outcome

Timeframe: Day 0 (Day of Procedure)

Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.

Outcome measures

Outcome measures
Measure	Balloon Device n=592 sinuses Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.	552 number of sinuses

SECONDARY outcome

Timeframe: 2 weeks

Population: Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.

Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living

Outcome measures

Outcome measures
Measure	Balloon Device n=181 Participants Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Mean Number of Days to Return to Normal Activities	2.3 days Standard Deviation 1.8

Adverse Events

Balloon Device

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Balloon Device n=203 participants at risk Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Respiratory, thoracic and mediastinal disorders Pneumonia	0.49% 1/203 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Balloon Device n=203 participants at risk Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
Eye disorders Peri-orbital edema	0.49% 1/203 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Sinus Infection	15.8% 32/203 • Number of events 47 • 1 year
Gastrointestinal disorders Dysphagia	0.49% 1/203 • Number of events 1 • 1 year
Ear and labyrinth disorders Sensorineural Hearing Loss	0.49% 1/203 • Number of events 1 • 1 year
Ear and labyrinth disorders Tinnitus	0.49% 1/203 • Number of events 1 • 1 year
Immune system disorders Allergic reaction to medication (antibiotic)	0.49% 1/203 • Number of events 2 • 1 year
General disorders Facial Pain	1.5% 3/203 • Number of events 3 • 1 year
General disorders Headache	2.0% 4/203 • Number of events 4 • 1 year

Additional Information

Clinical Director

Acclarent, Inc.

Phone: 650-687-5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60