Back to resultsClinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (DELIVER)
Primary Purpose
Sinusitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Stratus Microflow Ethmoid Spacer
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects age 17 years or older
- Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
- Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
Exclusion Criteria:
- Age < 17 years old
- History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
- Adequate anatomical distances for treatment
- Patient received oral steroid treatment within two weeks prior to day of surgery
- Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
- Contracted/underdeveloped ethmoid sinus
- Dehiscent lamina orbitalis
- Previous ethmoid surgery
- Ethmoid mucocele
- Extensive Nasal Polyps
- Asthmatic patients with aspirin sensitivity
- Pregnant or lactating females
Sites / Locations
- Lahey Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stratus Microflow Ethmoid Spacer
Arm Description
Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.
Outcomes
Primary Outcome Measures
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
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.
Secondary Outcome Measures
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
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.
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
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).
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
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.
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00791934
Brief Title
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Acronym
DELIVER
Official Title
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acclarent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study Design:
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stratus Microflow Ethmoid Spacer
Arm Type
Experimental
Arm Description
Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.
Intervention Type
Device
Intervention Name(s)
Stratus Microflow Ethmoid Spacer
Other Intervention Name(s)
Ethmoid Spacer
Intervention Description
The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.
Primary Outcome Measure Information:
Title
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
Description
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.
Time Frame
10 weeks post-procedure
Secondary Outcome Measure Information:
Title
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
Description
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.
Time Frame
10 weeks post surgery
Title
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
Description
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).
Time Frame
10 weeks post-procedure
Title
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
Description
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.
Time Frame
1 year
Title
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects age 17 years or older
Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
Exclusion Criteria:
Age < 17 years old
History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
Adequate anatomical distances for treatment
Patient received oral steroid treatment within two weeks prior to day of surgery
Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
Sinonasal tumors or obstructive lesions
History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
Contracted/underdeveloped ethmoid sinus
Dehiscent lamina orbitalis
Previous ethmoid surgery
Ethmoid mucocele
Extensive Nasal Polyps
Asthmatic patients with aspirin sensitivity
Pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Catalano, MD
Organizational Affiliation
Lahey Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
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