What is the CLiKX device studying for ear tube placement in otitis media?

The CLiKX device is being studied to evaluate its safety and effectiveness in placing ear tubes for patients with chronic otitis media and related conditions. Researchers aim to see if it can help place tubes accurately while minimizing risks during the procedure. The study is sponsored by ClinQure, Inc.

Who may be eligible for this otitis media clinical trial?

Patients aged 6 months and older who need tympanostomy tube insertion may be eligible. The study includes both children and adults with an ear canal diameter of at least 4 mm. People who are pregnant, have certain ear conditions, or known anesthesia reactions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this otitis media clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 6Months +

All Genders

ID07625657

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

Led by ClinQure, Inc. · Updated on 2026-07-20

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months +

All Genders

Eligibility Criteria

You may qualify if you...

Scheduled to undergo tympanostomy tube insertion
At least 6 months old at the time of consent
Ear canal diameter of at least 4 mm
Able to provide informed consent or have a parent/guardian provide consent with assent as appropriate for ages 7 to 21

You will not qualify if you...

Pregnant at the time of surgery
Known adverse reaction to anesthesia
Severe abnormalities or damage to the tympanic membrane
Presence of otitis externa or active acute otitis media
Ear canal diameter less than 4 mm
Ear drums with overly vertical or horizontal orientation
Anatomy that prevents visualization or access to the tympanic membrane
Any condition that may increase risk as judged by the investigator
Suspected middle ear tumors or vascular lesions
Acute sensorineural hearing loss
History of ear drum surgery
Presence of hemotympanum
Unable or unwilling to comply with study procedures and follow-up

Research Team

Crystal George

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