N/A
Completed N=63
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Source: ClinicalTrials.gov NCT00791934 ↗Enrolled (actual)
63
Serious AEs
3.2%
Results posted
Jul 2014
Primary outcomePrimary: Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline. — -1.91 scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline. |
-1.91 | — |
| SECONDARY Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure) |
— | — |
| SECONDARY Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg |
1 | — |
| SECONDARY Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline |
-1.54 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00791934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.