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
  Purpose

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.


Condition Intervention Phase
Sinusitis
Device: Stratus Microflow Ethmoid Spacer
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (DELIVER)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: August 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stratus Microflow Ethmoid Spacer
Temporary implantation of Ethmoid spacer with Kenalog-40 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, 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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791934

Locations
United States, Massachusetts
Xxx
Brighton, Massachusetts, United States
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: xxx xxx xxx
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00791934     History of Changes
Other Study ID Numbers: CPR005003
Study First Received: November 13, 2008
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014