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

NCT00791934 | Completed Results

• 1 other identifier: CPR005003
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)

  10 weeks post surgery

• Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg

  10 weeks post-procedure

• Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline

  1 year

• Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline

  10 weeks

Study Arms (1)

Stratus Microflow Ethmoid Spacer

EXPERIMENTAL

Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.

Device: Stratus Microflow Ethmoid Spacer

Interventions

Stratus Microflow Ethmoid Spacer DEVICE

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.

Also known as: Ethmoid Spacer

Stratus Microflow Ethmoid Spacer

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Clinical Director
• Organization: Acclarent, Inc.

lenglan1@its.jnj.com

650-687-5888

Study Officials

• Peter Catalano, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 6, 2024
• Results First Posted: July 14, 2014

Record last verified: 2024-07

Locations

US (1)