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NCT05915078 · ClinicalTrials.gov registry record
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
A clinical trial of Otitis Media and Acute Otitis Media, sponsored by Smith & Nephew.
- Recruiting
- Registry status
- 200
- Enrollment target
- 6
- Study locations
NCT05915078 is a study of Otitis Media and Acute Otitis Media that is actively recruiting participants, run by Smith & Nephew. The registered enrollment target is 200 participants, below the 4,329-participant average among 14 other Otitis Media trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT05915078, a study of Otitis Media and Acute Otitis Media, is actively recruiting participants, sponsored by Smith & Nephew.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 6
- Study locations
Study Summary
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation. The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).
Conditions Studied
Interventions
- COMBINATION_PRODUCT Iontophoresis and tube placement
Study Locations (6)
New Jersey
- Regional Otolaryngology Head and Neck Associates - Cherry Hill
- Rutgers Robert Wood Johnson Medical School - New Brunswick
Utah
- Ogden Clinic - Professional Center North - Ogden
- Peak Pediatric Ear, Nose and Throat - Provo
Kentucky
- Advanced ENT and Allergy - Louisville
New York
- Columbia University Vagelos College of Physicians and Surgeons - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2027-06-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05915078
The ClinicalTrials.gov registry entry for NCT05915078 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,329-participant average among 14 other Otitis Media trials with a reported enrollment target (95% lower). The listed sponsor is Smith & Nephew, which has 72 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Iontophoresis and tube placement is the first listed.
NCT05915078 reports 6 study locations spanning 4 distinct geographic areas - top geographies include New Jersey, Utah, Kentucky.
Frequently Asked Questions
What is clinical trial NCT05915078 about?
NCT05915078 is a clinical study titled "Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry". This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 cent...
What is the current status of trial NCT05915078?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2023-06-15. Estimated completion is 2027-06-30.
What conditions does trial NCT05915078 study?
This clinical trial studies the following conditions: Otitis Media, Acute Otitis Media, Otitis Media With Effusion.
What interventions are being tested in trial NCT05915078?
The interventions under investigation include: Iontophoresis and tube placement (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05915078?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05915078 being conducted?
This trial has 6 study locations across Kentucky, New Jersey, New York, Utah. 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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