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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Otitis Media; Otitis Media With Effusion; Acute Otitis Media
• Intervention / Treatment: Combination product: Iontophoresis and tube placement

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Catherine E Whittall, BsC, Ph.D; Phone Number: +44 7841 868997; Email: catherine.whittall@smith-nephew.com

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Recruiting
      • Advanced ENT and Allergy
      • Contact: Jennifer Leonard; Phone Number: 1185 502-893-0159; Email: jleonard@advancedentandallergy.com
      • Principal Investigator: Colin A Neumann, MD
      • Principal Investigator: Andrew R Gould, MD
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Recruiting
      • Regional Otolaryngology Head and Neck Associates
      • Contact: Megan Morgan
      • Principal Investigator: Ryan D Walker, MD
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Robert Wood Johnson Medical School
      • Contact: Kelvin M Kwong
      • Principal Investigator: Kelvin M Kwong, MD
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Vagelos College of Physicians and Surgeons
      • Principal Investigator: Lawrence Lustig, MD
  • Utah
    • Ogden, Utah, United States, 84403
      • Recruiting
      • Ogden Clinic - Professional Center North
      • Contact: Ashley Erickson
      • Principal Investigator: Douglas K Anderson, MD
    • Provo, Utah, United States, 84604
      • Recruiting
      • Peak Pediatric Ear, Nose and Throat
      • Contact: Jordan C Schramm
      • Principal Investigator: Jordan C Schramm, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participating centers will invite eligible patients ages 6 months to 17 years of age indicated for tympanostomy to participate in the Registry

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tula Tympanostomy; Patients undergoing in-office tympanostomy using the Tula® System	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability (physician reported)	Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation.	Day of procedure (day 0)
Tolerability (parent reported) - anesthesia	Count (and percentage) of patients whose parents strongly agree or agree with the statement 'My child tolerated the anesthesia process well'	Day of procedure (day 0)
Tolerability (parent reported) - procedure	Count (and percentage) of patients whose parents strongly agree or agree with the statement 'The tube placement portion of the procedure was tolerable for my child'.	Day of procedure (day 0)
Recovery (physician reported)	Count (and percentage) of patients who recovered once back with parent, or prior to leaving the clinic, following procedure completion as determined by physician's observation.	Day of procedure (day 0)
Recovery (parent reported)	Count (and percentage) of patients who returned to normal activities immediately following the procedure.	Day of procedure (day 0)
Anesthesia effectiveness - patients	Count (and percentage) of patients who completed iontophoresis with adequate anesthesia for tube placement in all treated ears as determined by the physician's evaluation of tympanic membrane anesthesia	Day of procedure (day 0)
Anesthesia effectiveness - ears	Count (and percentage) of ears that completed iontophoresis with adequate anesthesia for TT placement as determined by the physician's tympanic membrane anesthesia evaluation.	Day of procedure (day 0)
Tula Tympanostomy Tube retention	Count (and percentage) of patients at the first post-operative visit in which a Tula Tympanostomy Tube was successfully placed, with presence of the Tula Tympanostomy Tube across the tympanic membrane	1 month post procedure
Parent satisfaction (informed)	Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'I felt well informed and prepared to help me/my child complete the procedure'	1 month post-procedure
Parent satisfaction (siblings)	Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'If my child had a sibling who needed ear tubes, I would choose this procedure in the office instead of going under general anesthesia in the operating room'	1 month post-procedure
Overall parent satisfaction	Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'Overall, I am very satisfied with the in-office ear tube procedure'	1 month post-procedure
Parent satisfaction (recommendation)	Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'I would recommend this procedure to family/friends who have children who need ear tubes'	1 month post-procedure

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; local anesthesia; Otitis media; tympanostomy; office procedure
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: Tula Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No