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NCT01107379 · ClinicalTrials.gov registry record
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
A clinical trial, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- 203
- Enrollment target
NCT01107379: Completed study, sponsored by Integra LifeSciences Corporation.
NCT01107379 is a clinical trial that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 203 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01107379 has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- 203 participants
- Enrollment target
Study Summary
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
Primary Outcome
Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. 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 and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the 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 '
Interventions
- DEVICE Relieva Balloon Sinuplasty System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-07 |
What the finished NCT01107379 record still lists
NCT01107379 is an observational study that tracks outcomes without assigning an intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Relieva Balloon Sinuplasty System is the first listed.
NCT01107379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01107379 about?
NCT01107379 is a clinical study titled "Optimization and Refinement of Technique in In-Office Sinus Dilation 2". A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
What is the current status of trial NCT01107379?
This trial is currently completed. The enrollment target is 203 participants. The study started on 2010-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01107379?
The interventions under investigation include: Relieva Balloon Sinuplasty System (DEVICE).
Who is sponsoring clinical trial NCT01107379?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
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