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Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

Recruitingn/aAges 6 Months - 17 YearsAllSmith & Nephew, Inc.
NCT05915078 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System * Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use Exclusion Criteria: * Patients who are wards are not included
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What it tests

  • Iontophoresis and tube placement
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Where

6 sites
Advanced ENT and Allergy
Louisville, United States
Regional Otolaryngology Head and Neck Associates
Cherry Hill, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, United States
Columbia University Vagelos College of Physicians and Surgeons
New York, United States
Ogden Clinic - Professional Center North
Ogden, United States
Peak Pediatric Ear, Nose and Throat
Provo, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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