Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
- Conditions
- Acute Otitis MediaOtitis MediaOtitis Media With Effusion
- Interventions
- Combination Product: Iontophoresis and tube placement
- Registration Number
- NCT05915078
- Lead Sponsor
- Smith & Nephew, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Patients who are wards are not included
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tula Tympanostomy Iontophoresis and tube placement Patients undergoing in-office tympanostomy using the Tula® System
- Primary Outcome Measures
Name Time Method Procedure Success Day of procedure (day 0) Count (and percentage) of patients with successful placement of Tula Tympanostomy Tubes in all indicated ears in an office procedure
- Secondary Outcome Measures
Name Time Method Tolerability (physician reported) Day of procedure (day 0) Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation.
Overall parent satisfaction 1 month post-procedure 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'Tolerability (parent reported) - anesthesia Day of procedure (day 0) Count (and percentage) of patients whose parents strongly agree or agree with the statement 'My child tolerated the anesthesia process well'
Recovery (physician reported) Day of procedure (day 0) 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.
Recovery (parent reported) Day of procedure (day 0) Count (and percentage) of patients who returned to normal activities immediately following the procedure.
Anesthesia effectiveness - patients Day of procedure (day 0) 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
Parent satisfaction (informed) 1 month post-procedure 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'Anesthesia effectiveness - ears Day of procedure (day 0) Count (and percentage) of ears that completed iontophoresis with adequate anesthesia for TT placement as determined by the physician's tympanic membrane anesthesia evaluation.
Tula Tympanostomy Tube retention 1 month post procedure 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
Tolerability (parent reported) - procedure Day of procedure (day 0) 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'.
Parent satisfaction (siblings) 1 month post-procedure 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'Parent satisfaction (recommendation) 1 month post-procedure 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'
Trial Locations
- Locations (6)
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Regional Otolaryngology Head and Neck Associates
🇺🇸Cherry Hill, New Jersey, United States
Ogden Clinic - Professional Center North
🇺🇸Ogden, Utah, United States
Peak Pediatric Ear, Nose and Throat
🇺🇸Provo, Utah, United States
Columbia University Vagelos College of Physicians and Surgeons
🇺🇸New York, New York, United States
Advanced ENT and Allergy
🇺🇸Louisville, Kentucky, United States