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

NCT05915078 · tracked via the Priya Life Science USA tracker

Sponsor

Smith & Nephew, Inc.

Phase

Observational

Started

2023-06-15

Last updated

2024-07-23

Condition(s) studied

Otitis Media With EffusionAcute Otitis MediaOtitis Media

Investigational drug(s) / intervention(s)

Iontophoresis and tube placement

Iontophoresis and tube placement: Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System

Study summary

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).

Eligibility

Sex

ALL

Min age

6 Months

Max age

17 Years

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

Primary outcome measure(s)

Procedure Success — Day of procedure (day 0)
Count (and percentage) of patients with successful placement of Tula Tympanostomy Tubes in all indicated ears in an office procedure

Trial sites (6)

Facility	City	Region	Status
Advanced ENT and Allergy	Louisville	Kentucky	Recruiting
Regional Otolaryngology Head and Neck Associates	Cherry Hill	New Jersey	Recruiting
Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	Recruiting
Columbia University Vagelos College of Physicians and Surgeons	New York	New York	Recruiting
Ogden Clinic - Professional Center North	Ogden	Utah	Recruiting
Peak Pediatric Ear, Nose and Throat	Provo	Utah	Recruiting

More Smith & Nephew, Inc. trials in the USA

A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted Enrolling by invitation

JOURNEY II XR Safety and Effectiveness PMCF Active, not recruiting

LEGION Hinge Safety and Efficacy Study Active, not recruiting

Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts Active, not recruiting

AETOS Shoulder System Recruiting

Other trials for the same condition

Evaluating Laser Otoscope for Middle Ear Effusion Detection Starting soon

In-Office Clinical Study of the Solo+ TTD Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05915078 on ClinicalTrials.gov ↗ ← All trials in the USA