Evaluation of outcomes after in-office ear tube placement using the Tula System
Official title: Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Run by Smith & Nephew, Inc. · NCT05915078 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 6 Months to 17 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Smith & Nephew, Inc. Industry-sponsored |
| Locations | 6 sites (Louisville, Kentucky and 5 other locations) |
| Status | Recruiting |
| Started | June 15, 2023 |
| Main results expected | March 30, 2025 |
| Study ends | June 30, 2027 |
| Registry record updated | July 23, 2024 |
| Trial ID | NCT05915078 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 months to 17 years who require tympanostomy and are suitable for the Tula System procedure.
✕Probably not a fit
Patients who are wards or do not meet the inclusion criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown positive outcomes with similar in-office procedures, indicating potential for success with this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Parent-led Digital Ear Imaging to Detect Acute Otitis Media
Parents use a digital otoscope at home and AI analyzes the images to see if a child has acute otitis media, aiming to reduce unnecessary doctor visits.
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Using optical technology to diagnose ear infections in children
This study is testing if a new eye-based technology can help doctors better diagnose ear infections in children compared to the usual methods.
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CLiKX Tympanostomy Tube Delivery System for Ear Tube Placement
A device is being tested to place ear tubes in both children and adults to see if it can be safely and effectively position the tube during tympanostomy procedures.
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Families' views on antibiotic length and using a smartwatch to track children's symptoms
We will see if families are comfortable with shorter antibiotic courses and if a Garmin smartwatch can help track symptoms in children aged 4–17 with uncomplicated infections.
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Solo+ Tympanostomy Tube Device: Post-Market Follow-Up
This study tests how well the Solo+ tympanostomy tube device works in people who are getting or have already gotten ear tubes, by collecting doctor notes and patient/guardian experiences after the procedure.
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SWIR Otoscope: Testing a New Way to See Ear Infections in Kids
This study tests whether a short wave infrared (SWIR) otoscope can better identify middle ear fluid in children undergoing tympanostomy tube placement than a standard white light otoscope.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.