Condition: Otitis Media With Effusion · Acute Otitis Media · Otitis Media · Sponsor: Smith & Nephew, Inc.
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).
This description comes directly from the study's public registry record.
Catherine E Whittall, BsC, Ph.D · +44 7841 868997 · catherine.whittall@smith-nephew.com
Always discuss trial participation with your own doctor first.
| Advanced ENT and Allergy | Louisville, Kentucky, United States | Recruiting |
| Regional Otolaryngology Head and Neck Associates | Cherry Hill, New Jersey, United States | Recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick, New Jersey, United States | Recruiting |
| Columbia University Vagelos College of Physicians and Surgeons | New York, New York, United States | Recruiting |
| Ogden Clinic - Professional Center North | Ogden, Utah, United States | Recruiting |
| Peak Pediatric Ear, Nose and Throat | Provo, Utah, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05915078