Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorSmith & Nephew, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who are wards are not included
Trial population
Participating centers will invite eligible patients ages 6 months to 17 years of age indicated for tympanostomy to participate in the Registry
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Iontophoresis and tube placement
Combination productIontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Tula Tympanostomy1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov