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Recruiting NCT05915078

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

— Observational Otitis Media With Effusion Acute Otitis Media Otitis Media

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iontophoresis and tube placement.
Who it may be relevant to
Registry conditions: Otitis Media With Effusion, Acute Otitis Media, Otitis Media. Basic parameters: 6 months — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Procedure Success [Time frame: Day of procedure (day 0)]
Secondary outcome measures (12)
  • Tolerability (physician reported) [Time frame: Day of procedure (day 0)]
  • Tolerability (parent reported) - anesthesia [Time frame: Day of procedure (day 0)]
  • Tolerability (parent reported) - procedure [Time frame: Day of procedure (day 0)]
  • Recovery (physician reported) [Time frame: Day of procedure (day 0)]
  • Recovery (parent reported) [Time frame: Day of procedure (day 0)]
  • Anesthesia effectiveness - patients [Time frame: Day of procedure (day 0)]
  • Anesthesia effectiveness - ears [Time frame: Day of procedure (day 0)]
  • Tula Tympanostomy Tube retention [Time frame: 1 month post procedure]
  • Parent satisfaction (informed) [Time frame: 1 month post-procedure]
  • Parent satisfaction (siblings) [Time frame: 1 month post-procedure]
  • Overall parent satisfaction [Time frame: 1 month post-procedure]
  • Parent satisfaction (recommendation) [Time frame: 1 month post-procedure]

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 who are wards are not included

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • Advanced ENT and Allergy — Louisville
  • Regional Otolaryngology Head and Neck Associates — Cherry Hill
  • Rutgers Robert Wood Johnson Medical School — New Brunswick
  • Columbia University Vagelos College of Physicians and Surgeons — New York
  • Ogden Clinic - Professional Center North — Ogden
  • Peak Pediatric Ear, Nose and Throat — Provo

Identifiers

NCT: NCT05915078 · Tula Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗