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

Study Overview
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Brief Summary
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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).

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

Conditions
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Acute Otitis Media, Otitis Media, Otitis Media With Effusion

Intervention / Treatment
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* Combination Product: Iontophoresis and tube placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tula Tympanostomy<br>Patients undergoing in-office tympanostomy using the Tula® System | Combination Product: Iontophoresis and tube placement<br>* Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthesia, Otitis media, pediatric, tympanostomy, office procedure