Recruiting

Tula System

Sponsor:

Smith & Nephew, Inc.

Code:

NCT05915078

Conditions

Otitis Media With Effusion

Acute Otitis Media

Otitis Media

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Iontophoresis and tube placement

Study Details

Brief 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).

Conditions

Otitis Media With Effusion

Acute Otitis Media

Otitis Media

Study ID

NCT05915078

Start date

Jun 15, 2023

Status verified date

Jul, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Tula Tympanostomy

Patients undergoing in-office tympanostomy using the Tula® System

Interventions

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 measure

  • Procedure Success [ Time Frame: Day of procedure (day 0) ]

Central Contacts and Locations

Central contacts

Catherine E Whittall, BsC, Ph.D

+44 7841 868997catherine.whittall@smith-nephew.com

Locations

Advanced ENT and Allergy

Recruiting

Louisville, Kentucky, United States, 40220

Contacts

Jennifer Leonard

502-893-0159jleonard@advancedentandallergy.com

Principal Investigator:

Colin A Neumann, MD

Regional Otolaryngology Head and Neck Associates

Recruiting

Cherry Hill, New Jersey, United States, 08034

Principal Investigator:

Ryan D Walker, MD

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Kelvin M Kwong, MD

Columbia University Vagelos College of Physicians and Surgeons

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Lawrence Lustig, MD

Ogden Clinic - Professional Center North

Recruiting

Ogden, Utah, United States, 84403

Principal Investigator:

Douglas K Anderson, MD

Peak Pediatric Ear, Nose and Throat

Recruiting

Provo, Utah, United States, 84604

Principal Investigator:

Jordan C Schramm, MD

More Information

Sponsor

Smith & Nephew, Inc.

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Keywords

  • Otitis media
  • pediatric
  • tympanostomy
  • office procedure
  • local anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Smith & Nephew, Inc. on 2024-07-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.