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Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 23, 2024 (before its estimated March 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Mar 30, 2024 to Mar 30, 2025
    • Study sites: 4 to 6
    • Study completion date: Mar 30, 2027 to Jun 30, 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 16, 2023 to Jun 15, 2023
    • Site details revised at 4 of 4 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05915078
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Otitis Media With Effusion, Acute Otitis Media, Otitis Media
Related terms Otitis Media, Otitis Media with Effusion
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov