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

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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

Tracking Information
First Submitted Date  ICMJE November 13, 2008
First Posted Date  ICMJE November 17, 2008
Results First Submitted Date  ICMJE May 6, 2014
Results First Posted Date  ICMJE July 14, 2014
Last Update Posted Date July 25, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline. [ Time Frame: 10 weeks post-procedure ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
  • Improvement in Sinus CT Lund-Mackay scores [ Time Frame: approximately 2 months post surgery ]
  • Safety as assessed by the occurrence of adverse events [ Time Frame: approximately two months following surgery ]
Change History Complete list of historical versions of study NCT00791934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
  • Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure) [ Time Frame: 10 weeks post surgery ]
    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 [ Time Frame: 10 weeks post-procedure ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 10 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
Ocular Safety and Quality of Life [ Time Frame: 2 months post surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Official Title  ICMJE Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE Device: Stratus Microflow Ethmoid Spacer
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.
Other Name: Ethmoid Spacer
Study Arms  ICMJE Experimental: Stratus Microflow Ethmoid Spacer
Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.
Intervention: Device: Stratus Microflow Ethmoid Spacer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2012)
63
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2008)
62
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791934
Other Study ID Numbers  ICMJE CPR005003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acclarent
Study Sponsor  ICMJE Acclarent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Catalano, MD Lahey Clinic
PRS Account Acclarent
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP