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NCT00791934 · ClinicalTrials.gov registry record · NA
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
A NA study, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT00791934: Completed NA study, sponsored by Integra LifeSciences Corporation.
NCT00791934 is a NA study that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00791934, a NA study, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE Stratus Microflow Ethmoid Spacer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-11 |
| Phase | NA |
What the finished NCT00791934 record still lists
NCT00791934 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Stratus Microflow Ethmoid Spacer is the first listed.
NCT00791934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00791934 about?
NCT00791934 is a clinical study titled "Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide". 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.
What is the current status of trial NCT00791934?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2008-08. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00791934?
The interventions under investigation include: Stratus Microflow Ethmoid Spacer (DEVICE).
Who is sponsoring clinical trial NCT00791934?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00791934's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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