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
Qualifiers
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 design
Treatments tested in this trial
- Iontophoresis and tube placement
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov