Evaluation of the CLiKX Device for Safe and Effective Ear Tube Placement in Children and Adults

What this Trial Is About

This research aims to evaluate the safety and performance of the CLiKX device, which is designed to place ear tubes in children and adults. The ear tubes, also known as tympanostomy tubes, are used to treat chronic ear fluid and other conditions where a doctor decides an ear tube is needed. The study focuses on patients aged 6 months and older who require tympanostomy tube insertion for chronic otitis media or similar conditions. Participants will undergo tympanostomy tube placement using the CLiKX device, a handheld automated surgical tool that helps create precise incisions and place the tube accurately. The procedure may be done without anesthesia, with local anesthesia, or if necessary, with mild sedation or general anesthesia. The study will follow patients through baseline, procedure, discharge, and a 30-day follow-up visit to assess device performance, procedural success, and safety. During the study, researchers will monitor how well the procedure is tolerated, tracking pain levels using various scales and evaluating caregiver satisfaction and physician evaluation of the procedure. Safety will be assessed by recording adverse events and medication use up to 30 days after the procedure. Participants will have several study visits including baseline, procedure, post-procedure at discharge, and a follow-up visit one month later.

CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes