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NCT01202578 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Tympanostomy Tube Delivery System
A Phase 2 study of Acute Otitis Media and Otitis Media With Effusion, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 4
- Study locations
NCT01202578 is a Phase 2 study of Acute Otitis Media and Otitis Media With Effusion that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 53 participants, below the 401-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01202578, a Phase 2 study of Acute Otitis Media and Otitis Media With Effusion, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Conditions Studied
Interventions
- DEVICE tympanostomy tube
Study Locations (4)
Florida
- South Coast ENT - Port Saint Lucie
Kentucky
- Advanced ENT and Allergy - Louisville
Texas
- Ear Medical Group - San Antonio
Washington
- Evergreen Sinus Center - Kirkland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2010-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01202578
The ClinicalTrials.gov registry entry for NCT01202578 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 401-participant average among 8 other Acute Otitis Media trials with a reported enrollment target (87% lower). The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which tympanostomy tube is the first listed.
NCT01202578 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Kentucky, Texas.
Frequently Asked Questions
What is clinical trial NCT01202578 about?
NCT01202578 is a clinical study titled "Evaluation of the Tympanostomy Tube Delivery System". The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
What is the current status of trial NCT01202578?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2010-09. Estimated completion is 2010-12.
What conditions does trial NCT01202578 study?
This clinical trial studies the following conditions: Acute Otitis Media, Otitis Media With Effusion.
What interventions are being tested in trial NCT01202578?
The interventions under investigation include: tympanostomy tube (DEVICE).
Who is sponsoring clinical trial NCT01202578?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01202578 being conducted?
This trial has 4 study locations across Florida, Kentucky, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.