Evaluation of outcomes after in-office ear tube placement using the Tula System
Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
This study is testing a new way to place ear tubes in kids aged 6 months to 17 years using local anesthesia to see how safe and effective it is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 6 Months to 17 Years |
| Sex | All |
| Sponsor | Smith & Nephew, Inc. Industry-sponsored |
| Locations | 6 sites (Louisville, Kentucky and 5 other locations) |
| Trial ID | NCT05915078 on ClinicalTrials.gov |
What this trial studies
This observational registry collects real-world data on patients aged 6 months to 17 years undergoing tympanostomy with the Tula System, which utilizes local anesthesia for ear tube placement. The study aims to evaluate the safety, efficacy, and tolerability of this procedure across multiple centers in the US. Up to 200 patients will be enrolled, and their outcomes will be monitored for up to 6 months following tube removal. The Tula System combines iontophoresis for anesthesia and a specialized delivery system for tube placement.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 17 years who require tympanostomy and are suitable for the Tula System procedure.
Not a fit: Patients who are wards or do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of in-office ear tube placements for children with otitis media.
How similar studies have performed: Previous studies have shown positive outcomes with similar in-office procedures, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System * Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use Exclusion Criteria: * Patients who are wards are not included
Where this trial is running
Louisville, Kentucky and 5 other locations
- Advanced ENT and Allergy — Louisville, Kentucky, United States (Recruiting)
- Regional Otolaryngology Head and Neck Associates — Cherry Hill, New Jersey, United States (Recruiting)
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Recruiting)
- Columbia University Vagelos College of Physicians and Surgeons — New York, New York, United States (Recruiting)
- Ogden Clinic - Professional Center North — Ogden, Utah, United States (Recruiting)
- Peak Pediatric Ear, Nose and Throat — Provo, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Catherine E Whittall, BsC, Ph.D
- Email: catherine.whittall@smith-nephew.com
- Phone: +44 7841 868997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.