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

Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Device: Stratus Microflow Ethmoid Spacer

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Stratus Microflow Ethmoid Spacer; Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.

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 Names: Ethmoid Spacer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks post surgery
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).	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.	1 year
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.	10 weeks

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Peter Catalano, MD, Lahey Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (ESTIMATE): November 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 18, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: CPR005003