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

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915078
• Other study ID #: Tula Registry
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: March 30, 2027

Study information

• Verified date: July 2023
• Source: Smith & Nephew, Inc.
• Contact: Catherine E Whittall, BsC, Ph.D
• Phone: +44 7841 868997
• Email: catherine.whittall[@]smith-nephew.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media
• Otitis Media With Effusion

Intervention

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

Locations

Country	Name	City	State
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University Vagelos College of Physicians and Surgeons	New York	New York
United States	Peak Pediatric Ear, Nose and Throat	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerability (physician reported)	Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation.	Day of procedure (day 0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Recovery (parent reported)	Count (and percentage) of patients who returned to normal activities immediately following the procedure.	Day of procedure (day 0)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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