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NCT01685229 · ClinicalTrials.gov registry record
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
A clinical trial of Sinusitis, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- 198
- Enrollment target
- 20
- Study locations
NCT01685229: Completed study of Sinusitis, sponsored by Integra LifeSciences Corporation.
NCT01685229 is a study of Sinusitis that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 198 participants, above the 114-participant average among 12 other Sinusitis trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01685229, a study of Sinusitis, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- 198 participants
- Enrollment target
- 20
- Study locations
Study Summary
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
Primary Outcome
The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best). The Primary Endpoint is the comparison of change in total CSS score over 24
Conditions Studied
Interventions
- DEVICE Balloon sinus dilation
- DRUG Medical Management
Study Locations (20)
Georgia
- - Atlanta
- - Savannah
- - Vidalia
Texas
- - Frisco
- - McKinney
- - Plano
Virginia
- - Charlottesville
- - Norfolk
- - Richmond
Florida
- - Miami
- - Tampa
Illinois
- - Chicago
- - Rockford
Wisconsin
- - Beaver Dam
- - Wauwatosa
Colorado
- - Denver
Indiana
- - South Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2012-09-01 |
| Est. Completion | 2015-08-01 |
What the finished NCT01685229 record still lists
NCT01685229 is an observational study that tracks outcomes without assigning an intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 12 other Sinusitis trials with a reported enrollment target (74% higher).
The record links to 1 condition, with Sinusitis appearing as the primary indexed condition, and to 2 interventions - of which Balloon sinus dilation is the first listed.
NCT01685229 names 20 study sites across 11 states, led by Georgia, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT01685229 about?
NCT01685229 is a clinical study titled "Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis". This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
What is the current status of trial NCT01685229?
This trial is currently completed. The enrollment target is 198 participants. The study started on 2012-09-01. Estimated completion is 2015-08-01.
What conditions does trial NCT01685229 study?
This clinical trial studies the following conditions: Sinusitis.
What interventions are being tested in trial NCT01685229?
The interventions under investigation include: Balloon sinus dilation (DEVICE), Medical Management (DRUG).
Who is sponsoring clinical trial NCT01685229?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01685229 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sinusitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01685229's enrollment target sits among peer trials
198 4th of 12 higher than 9 of 12 other Sinusitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sinusitis 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.
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