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

Recruiting now

Conditions studied: Otitis Media With Effusion, Acute Otitis Media, Otitis Media

In brief

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).

Key facts

Study ID

NCT05915078

Run by

Smith & Nephew, Inc.

People needed

200

Starts

2023-06-15

Expected to finish

2027-06-30

Last updated by the study team

2024-07-23

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients who are wards are not included

Where it is running

• Advanced ENT and Allergy — Louisville, Kentucky, United States (enrolling)
• Regional Otolaryngology Head and Neck Associates — Cherry Hill, New Jersey, United States (enrolling)
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
• Columbia University Vagelos College of Physicians and Surgeons — New York, New York, United States (enrolling)
• Ogden Clinic - Professional Center North — Ogden, Utah, United States (enrolling)
• Peak Pediatric Ear, Nose and Throat — Provo, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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