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NCT01496287 · ClinicalTrials.gov registry record · NA
Tympanostomy Tube Placement in Children in the Office (Inova Study)
A NA study of Otitis Media, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01496287 is a NA study of Otitis Media that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 70 participants, below the 4,339-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01496287, a NA study of Otitis Media, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
Conditions Studied
Interventions
- DEVICE Tube Delivery System (TDS)
Study Locations (1)
Florida
- South Coast Ear, Nose & Throat - Port Saint Lucie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01496287
The ClinicalTrials.gov registry entry for NCT01496287 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,339-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower). The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Tube Delivery System (TDS) is the first listed.
NCT01496287 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01496287 about?
NCT01496287 is a clinical study titled "Tympanostomy Tube Placement in Children in the Office (Inova Study)". The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
What is the current status of trial NCT01496287?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2011-12. Estimated completion is 2012-04.
What conditions does trial NCT01496287 study?
This clinical trial studies the following conditions: Otitis Media.
What interventions are being tested in trial NCT01496287?
The interventions under investigation include: Tube Delivery System (TDS) (DEVICE).
Who is sponsoring clinical trial NCT01496287?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01496287 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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