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

Recruiting now · Not applicable

Conditions studied: Otitis Media, Otitis Media Chronic, Otitis Media Effusion, Otitis Media Recurrent, Otitis Media in Children

In brief

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..

Key facts

Study ID

NCT07625657

Run by

ClinQure, Inc.

People needed

80

Starts

2026-06-01

Expected to finish

2027-08-01

Last updated by the study team

2026-07-20

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is scheduled to undergo tympanostomy tube insertion.
• Subject is ≥ 6 months old at the time of informed consent.
• Subject has an ear canal diameter of ≥ 4 mm.
• Subject is able and willing to provide informed consent or subject's parent/guardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).

You may not qualify if…

• Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.
• Subjects with known adverse reaction to anesthesia.
• Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.
• Subjects with otitis externa.
• Subjects with active acute otitis media.
• Subjects with an ear canal diameter < 4 mm.
• Ear drums that are overly vertical or horizontal
• Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.
• Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.
• Subjects with suspected middle ear tumors or vascular lesions.
• Subjects diagnosed with acute sensorial hearing loss
• Subjects with a history of surgery involving the ear drum.
• Subjects with hemotympanum.
• Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.

Where it is running

• Advanced ENT and Allergy, PLLC — Louisville, Kentucky, United States (enrolling)
• Clinical Investigations of Texas — Mesquite, Texas, United States

Full record on ClinicalTrials.gov

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