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

Launched by SMITH & NEPHEW, INC. · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a procedure called tympanostomy, which involves placing ear tubes in children with ear infections. Specifically, it is looking at the use of the Tula® System, a new method that uses a special device to place the tubes while minimizing discomfort. The trial will involve children aged 6 months to 17 years who need this procedure and will be conducted at up to 20 centers across the United States with around 200 participants.

If your child is between 6 months and 17 years old and is a candidate for ear tube placement using the Tula System, they may be eligible to join the study. Participants will receive standard medical care during the procedure, and the research team will follow up with them for up to 6 months to see how they are doing after the tubes are placed. This trial aims to gather real-world information about the procedure's outcomes to help improve care for children with ear problems.

Gender

ALL

Eligibility 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