Actively Recruiting
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Led by Smith & Nephew, Inc. · Updated on 2024-07-23
200
Participants Needed
6
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula4 System
- Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use
You will not qualify if you...
- Patients who are wards are not included
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40220
Actively Recruiting
2
Regional Otolaryngology Head and Neck Associates
Cherry Hill, New Jersey, United States, 08034
Actively Recruiting
3
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
4
Columbia University Vagelos College of Physicians and Surgeons
New York, New York, United States, 10032
Actively Recruiting
5
Ogden Clinic - Professional Center North
Ogden, Utah, United States, 84403
Actively Recruiting
6
Peak Pediatric Ear, Nose and Throat
Provo, Utah, United States, 84604
Actively Recruiting
Research Team
C
Catherine E Whittall, BsC, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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