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

Smith & Nephew

Status: Enrolling

Conditions: Acute Otitis Media; Otitis Media With Effusion; Otitis Media

Treatments: Combination Product: Iontophoresis and tube placement

Study type: Observational

Funder types: Industry

Identifiers

NCT05915078

Tula Registry

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Tula Tympanostomy

Description:

Patients undergoing in-office tympanostomy using the Tula® System

Treatment:

Combination Product: Iontophoresis and tube placement