NCT05915078View on ClinicalTrials.gov

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

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

June 15, 2023

Primary Completion Date

March 30, 2025

Study Completion Date

June 30, 2027

Conditions
Otitis Media With EffusionAcute Otitis MediaOtitis Media
Interventions
COMBINATION_PRODUCT

Iontophoresis and tube placement

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

Trial Locations (6)

10032

RECRUITING

Columbia University Vagelos College of Physicians and Surgeons, New York

40220

RECRUITING

Advanced ENT and Allergy, Louisville

84403

RECRUITING

Ogden Clinic - Professional Center North, Ogden

84604

RECRUITING

Peak Pediatric Ear, Nose and Throat, Provo

08034

RECRUITING

Regional Otolaryngology Head and Neck Associates, Cherry Hill

08901

RECRUITING

Rutgers Robert Wood Johnson Medical School, New Brunswick

All Listed Sponsors
lead

Smith & Nephew, Inc.

INDUSTRY