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

NCT ID: NCT00791934

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stratus Microflow Ethmoid Spacer

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

Group Type: EXPERIMENTAL

Stratus Microflow Ethmoid Spacer

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Ethmoid Spacer

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acclarent

INDUSTRY

Sponsor Role: collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Catalano, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic

Locations

Lahey Clinic

Burlington, Massachusetts, United States

Countries

United States

Other Identifiers

CPR005003

Identifier Type: -

Identifier Source: org_study_id