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

November 13, 2008
September 4, 2012
August 2008
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00791934 on ClinicalTrials.gov Archive Site
  • 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 ]
Ocular Safety and Quality of Life [ Time Frame: 2 months post surgery ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (DELIVER)

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sinusitis
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
Experimental: Stratus Microflow Ethmoid Spacer
Temporary implantation of Ethmoid spacer with Kenalog-40 for 28 days.
Intervention: Device: Stratus Microflow Ethmoid Spacer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00791934
CPR005003
No
Acclarent
Acclarent
Not Provided
Principal Investigator: xxx xxx xxx
Acclarent
August 2012

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