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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Smith & Nephew, Inc.
Study ID
NCT05915078
Status
Recruiting
Apply to this trial

Conditions

  • Acute Otitis Media
  • Otitis Media
  • Otitis Media With Effusion

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Iontophoresis and tube placement — COMBINATION_PRODUCT
    Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System

Study Details

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).

Key Dates

Start date
Jun 15, 2023
Status verified
Jul 2024
Primary completion
Mar 30, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Tula Tympanostomy
    Patients undergoing in-office tympanostomy using the Tula® System

Primary Outcome Measure

Procedure Success [ Time Frame: Day of procedure (day 0) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Advanced ENT and AllergyLouisvilleKentucky40220
Jennifer Leonard
[email protected]
502-893-0159
Colin A Neumann, MD (PRINCIPAL_INVESTIGATOR)
Andrew R Gould, MD (PRINCIPAL_INVESTIGATOR)
Regional Otolaryngology Head and Neck AssociatesCherry HillNew Jersey08034
Megan Morgan
Ryan D Walker, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901
Kelvin M Kwong
Kelvin M Kwong, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Vagelos College of Physicians and SurgeonsNew YorkNew York10032
Lawrence Lustig, MD (PRINCIPAL_INVESTIGATOR)
Ogden Clinic - Professional Center NorthOgdenUtah84403
Ashley Erickson
Douglas K Anderson, MD (PRINCIPAL_INVESTIGATOR)
Peak Pediatric Ear, Nose and ThroatProvoUtah84604
Jordan C Schramm
Jordan C Schramm, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Louisville, KY

By research site
Advanced ENT and Allergy· Louisville, KYRegional Otolaryngology Head and Neck Associates· Cherry Hill, NJRutgers Robert Wood Johnson Medical School· New Brunswick, NJColumbia University Vagelos College of Physicians and Surgeons· New York, NYOgden Clinic - Professional Center North· Ogden, UTPeak Pediatric Ear, Nose and Throat· Provo, UT

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