Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00791934
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : July 14, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Acclarent

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sinusitis
Intervention Device: Stratus Microflow Ethmoid Spacer
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 63
Completed 48 [1]
Not Completed 15
Reason Not Completed
Withdrawal by Subject             2
Did not consent for extended follow-up             13
[1]
Follow-up extended to 1 yr. 13 subjects chose not to participate in the extension.
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description 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 Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants
47.24  (14.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
24
  38.1%
Male
39
  61.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.6%
White
58
  92.1%
More than one race
0
   0.0%
Unknown or Not Reported
3
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
1.Primary Outcome
Title Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description:
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 Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.91  (1.94)
2.Secondary Outcome
Title Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description:
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 Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description:
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 Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
1
4.Secondary Outcome
Title Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description:
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 Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.36  (1.27)
5.Secondary Outcome
Title Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description:
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 Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.54  (0.99)
Time Frame Up to 10 weeks
Adverse Event Reporting Description Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting
 
Arm/Group Title Stratus Microflow Ethmoid Spacer
Hide Arm/Group Description Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
All-Cause Mortality
Stratus Microflow Ethmoid Spacer
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stratus Microflow Ethmoid Spacer
Affected / at Risk (%) # Events
Total   2/63 (3.17%)    
Respiratory, thoracic and mediastinal disorders   
Wing Detachment from device  [1]  2/63 (3.17%)  2
Indicates events were collected by systematic assessment
[1]
Device wing separated from the body of the device.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Stratus Microflow Ethmoid Spacer
Affected / at Risk (%) # Events
Total   19/63 (30.16%)    
Nervous system disorders   
Headache  [1]  5/63 (7.94%)  5
Respiratory, thoracic and mediastinal disorders   
Nasal Pain  [1]  12/63 (19.05%)  14
Nasal Stuffiness  [1]  14/63 (22.22%)  17
Indicates events were collected by systematic assessment
[1]
Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Director
Organization: Acclarent, Inc.
Phone: 650-687-5888
Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00791934     History of Changes
Other Study ID Numbers: CPR005003
First Submitted: November 13, 2008
First Posted: November 17, 2008
Results First Submitted: May 6, 2014
Results First Posted: July 14, 2014
Last Update Posted: July 25, 2014