Trial Outcomes & Findings for Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (NCT NCT00791934)

Results Overview

The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. 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'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

10 weeks post-procedure

Results posted on

2024-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Stratus Microflow Ethmoid Spacer Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
Overall Study STARTED	63
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Stratus Microflow Ethmoid Spacer Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
Overall Study Withdrawal by Subject	2
Overall Study Did not consent for extended follow-up	13

Baseline Characteristics

Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratus Microflow Ethmoid Spacer n=63 Participants Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Age, Continuous	47.24 years STANDARD_DEVIATION 14.87 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks post-procedure

Population: A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.

The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. 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'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.

Outcome measures

Outcome measures
Measure	Stratus Microflow Ethmoid Spacer n=58 Participants Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.	-1.91 scores on a scale Standard Deviation 1.94

SECONDARY outcome

Timeframe: 10 weeks post surgery

Population: The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.

The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.

Outcome measures

Outcome measures
Measure	Stratus Microflow Ethmoid Spacer n=53 Participants Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)	0 participants

SECONDARY outcome

Timeframe: 10 weeks post-procedure

Population: The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.

Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of \> 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).

Outcome measures

Outcome measures
Measure	Stratus Microflow Ethmoid Spacer n=53 Participants Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg	1 participants

SECONDARY outcome

Timeframe: 1 year

Population: The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.

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, 10 weeks, and 1 year 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

Outcome measures
Measure	Stratus Microflow Ethmoid Spacer n=47 Participants Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline	-1.36 scores on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: 10 weeks

Population: The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.

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, 10 weeks, and 1 year 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

Outcome measures
Measure	Stratus Microflow Ethmoid Spacer n=58 Participants Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline	-1.54 scores on a scale Standard Deviation 0.99

Adverse Events

Stratus Microflow Ethmoid Spacer

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stratus Microflow Ethmoid Spacer n=63 participants at risk Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Respiratory, thoracic and mediastinal disorders Wing Detachment from device	3.2% 2/63 • Number of events 2 • Up to 10 weeks Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting

Other adverse events

Other adverse events
Measure	Stratus Microflow Ethmoid Spacer n=63 participants at risk Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
Nervous system disorders Headache	7.9% 5/63 • Number of events 5 • Up to 10 weeks Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting
Respiratory, thoracic and mediastinal disorders Nasal Pain	19.0% 12/63 • Number of events 14 • Up to 10 weeks Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting
Respiratory, thoracic and mediastinal disorders Nasal Stuffiness	22.2% 14/63 • Number of events 17 • Up to 10 weeks 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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60