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

Sinusitis Clinical Trial

— DELIVER  

Official title:

Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791934
• Other study ID #: CPR005003
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2008
• Last updated: July 18, 2014
• Start date: August 2008
• Est. completion date: November 2011

Study information

• Verified date: July 2014
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)	The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.	10 weeks post surgery	Yes
Secondary	Number of Participants With Either a Change in Intraocular Pressure (IOP) =10mmHg OR Documented IOP > 21 mmHg	Change in Intra-Ocular Pressure (IOP) of = 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).	10 weeks post-procedure	Yes
Secondary	Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	1 year	No
Secondary	Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	10 weeks	No