Actively Recruiting
Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula4 System: a Prospective, Multi-center Registry
Led by Smith & Nephew, Inc. · Updated on 2024-07-23
200
Participants Needed
6
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world data on children aged 6 months to 17 years undergoing an in-office ear tube placement procedure called tympanostomy using the Tula4 System. This prospective, single-arm, multicenter registry aims to evaluate the outcomes and experiences associated with this FDA-approved system, which has been previously studied for safety and tolerability in pediatric patients. The study is sponsored by Smith & Nephew, Inc. and involves up to 20 centers across the US. The Tula System includes two main components: the Tula Iontophoresis System, which delivers the TYMBION12 otic anesthetic to numb the ear drum, and the Tula Tube Delivery System, which is used to place the ear tubes. Patients will receive their treatment during a single in-office visit, and no comparison groups are included since this is an observational registry. The procedure is performed following the System Instructions For Use, and patients are treated as part of standard medical care. Participants will be monitored with outcome data collected up to six months following the extrusion or removal of their tubes. Assessments include procedure success, tolerability and recovery reported by physicians and parents on the day of the procedure, anesthesia effectiveness, tube retention after one month, and various measures of parent satisfaction. This follow-up helps researchers understand the real-world performance and patient experience with the Tula System over time.
CONDITIONS
Brief 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of procedure (day 0)
Participants undergo in-office tympanostomy using the Tula® System, including iontophoretic delivery of anesthetic and tube placement.
1 visit (in-person)
Duration - 1 month post-procedure
Participants are monitored for tube retention and parent satisfaction following the procedure.
1 follow-up visit (in-person)
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
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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