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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Combination product
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Kentucky
Advanced ENT and Allergy
RECRUITING
Louisville
New Jersey
Regional Otolaryngology Head and Neck Associates
RECRUITING
Cherry Hill
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
Columbia University Vagelos College of Physicians and Surgeons
RECRUITING
New York
Utah
Ogden Clinic - Professional Center North
RECRUITING
Ogden
Peak Pediatric Ear, Nose and Throat
RECRUITING
Provo
Contact Information
Primary
Catherine E Whittall, BsC, Ph.D
catherine.whittall@smith-nephew.com
+44 7841 868997
Time Frame
Start Date: 2023-06-15
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 200
Treatments
Tula Tympanostomy
Patients undergoing in-office tympanostomy using the Tula® System
Sponsors
Leads: Smith & Nephew, Inc.

This content was sourced from clinicaltrials.gov