Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Recruiting
Observational Study
Otitis Media With Effusion
Acute Otitis Media
Otitis Media
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 6 Months – 17
- Sex
- Any
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- Smith & Nephew, Inc. · Industry
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About This Trial
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 inclu…
Trial Locations
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Eligibility Criteria
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 wh…
Contacts