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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Acclarent

ClinicalTrials.gov Identifier:

NCT00791934

First received: November 13, 2008

Last updated: September 4, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 13, 2008

Last Updated Date

September 4, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of adverse events [ Time Frame: 10 weeks post-procedure ] [ Designated as safety issue: Yes ]
Change in Lund-MacKay CT score [ Time Frame: 10 weeks post-procedure ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety as assessed by the occurrence of adverse events [ Time Frame: approximately two months following surgery ] [ Designated as safety issue: Yes ]
Improvement in Sinus CT Lund-Mackay scores [ Time Frame: approximately 2 months post surgery ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00791934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in best corrected visual acuity (BCVA) [ Time Frame: 10 weeks post surgery ] [ Designated as safety issue: Yes ]
Change in intra-ocular pressure (IOP) [ Time Frame: 10 weeks post-procedure ] [ Designated as safety issue: Yes ]
Change in mean sino-nasal outcome test-20 (SNOT-20; quality of life) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Ocular Safety and Quality of Life [ Time Frame: 2 months post surgery ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 (DELIVER)

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 Kenalog-40, over a period of 28 days.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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, consisting of a sheath and needle. It is retained in the Ethmoid complex through the use of flexible anchoring wings. The surgeon has the option of suturing the device inside of the nose for additional retention, if desired.

In this protocol, Kenalog-40 (triamcinolone acetonide) will be administered into the Spacer instead of saline. The perforated membrane will then allow the Kenalog-40 to be released over a period of 28 days into the surrounding tissue to combat inflammation in a local, direct, and slow-release fashion. At the end of the time period, the device can be removed with standard instrumentation, during a follow-up office visit.

Other Name: Ethmoid Spacer

Study Arm (s)

Experimental: Stratus Microflow Ethmoid Spacer

Temporary implantation of Ethmoid spacer with Kenalog-40 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

Enrollment ^ICMJE

Completion Date

November 2011

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

Gender

Both

Ages

17 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00791934

Other Study ID Numbers ^ICMJE

CPR005003

Has Data Monitoring Committee

Responsible Party

Acclarent

Study Sponsor ^ICMJE

Acclarent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

xxx xxx

xxx

Information Provided By

Acclarent

Verification Date

August 2012

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

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