NCT05915078 Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
| NCT ID | NCT05915078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Smith & Nephew, Inc. |
| Condition | Otitis Media With Effusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-06-15 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-06-15 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05915078 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 17 Years, studying Otitis Media With Effusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05915078 currently recruiting?
Yes, NCT05915078 is actively recruiting participants. Contact the research team at catherine.whittall@smith-nephew.com for enrollment information.
Where is the NCT05915078 trial being conducted?
This trial is being conducted at Louisville, United States, Cherry Hill, United States, New Brunswick, United States, New York, United States and 2 additional locations.
Who is sponsoring the NCT05915078 clinical trial?
NCT05915078 is sponsored by Smith & Nephew, Inc.. The trial plans to enroll 200 participants.