An observational study in Otitis Media With Effusion, Acute Otitis Media and Otitis Media, sponsored by Smith & Nephew, Inc.. Recruiting at 6 sites in United States. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Smith & Nephew, Inc. · Observational
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).
85 studies on the registry are indexed under Otitis Media with Effusion; 15 are open to participants now.
This study's planned enrollment of 200 is above the median of 125 across 20 observational studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Smith & Nephew, Inc. is the lead sponsor of 133 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participating centers will invite eligible patients ages 6 months to 17 years of age indicated for tympanostomy to participate in the Registry
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Procedure Success
Count (and percentage) of patients with successful placement of Tula Tympanostomy Tubes in all indicated ears in an office procedure
Time frame: Day of procedure (day 0)
Tolerability (physician reported)
Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation.
Time frame: 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'
Time frame: 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'.
Time frame: 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.
Time frame: Day of procedure (day 0)
Recovery (parent reported)
Count (and percentage) of patients who returned to normal activities immediately following the procedure.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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'
Time frame: 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'
Time frame: 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'
Time frame: 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'
Time frame: 1 month post-procedure
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.