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

Last updated: July 19, 2024
Sponsor: Smith & Nephew, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Otitis (Pediatric)

Otitis Media

Ear Infections (Pediatric)

Treatment

Iontophoresis and tube placement

Clinical Study ID

NCT05915078
Tula Registry
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomyin-office using the Tula® System

  • Patients who are candidates for in-office tube placement using the Tula Systemaccording to the System Instructions For Use

Exclusion

Exclusion Criteria:

  • Patients who are wards are not included

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Iontophoresis and tube placement
Phase:
Study Start date:
June 15, 2023
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Advanced ENT and Allergy

    Louisville, Kentucky 40220
    United States

    Active - Recruiting

  • Regional Otolaryngology Head and Neck Associates

    Cherry Hill, New Jersey 08034
    United States

    Active - Recruiting

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Columbia University Vagelos College of Physicians and Surgeons

    New York, New York 10032
    United States

    Active - Recruiting

  • Ogden Clinic - Professional Center North

    Ogden, Utah 84403
    United States

    Active - Recruiting

  • Peak Pediatric Ear, Nose and Throat

    Provo, Utah 84604
    United States

    Active - Recruiting

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