CLiKX Tympanostomy Tube Delivery System for Ear Tube Placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study conducted at multiple sites to evaluate the safety and effectiveness of the CLiKX device for tympanostomy tube placement. The study assesses procedural success, including accurate myringotomy and correct tube delivery, and monitors device-related adverse events during the procedure. Participants include patients aged 6 months and older undergoing tympanostomy tube insertion, with follow-up for 30 days post-procedure to capture safety and tolerability data. Secondary goals include evaluating procedure workflow and overall device performance. The study supports the intended clinical use of CLiKX for facilitating myringotomy and tube placement in real-world settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is scheduled to undergo tympanostomy tube insertion.
2. Subject is ≥ 6 months old at the time of informed consent.
3. Subject has an ear canal diameter of ≥ 4 mm.
4. 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).

Exclusion Criteria:

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

Where it's running

• Advanced ENT and Allergy, PLLC
  Louisville, Kentucky, United States Recruiting
• Clinical Investigations of Texas
  Mesquite, Texas, United States Recruiting
• Texas Children's Hospital - West Campus
  Houston, Texas, United States Not yet recruiting
• Texas Children's Hospital - Woodlands Campus
  The Woodlands, Texas, United States Not yet recruiting

Study contacts

• Study coordinator: Crystal George
• Email: crystal@clinqure.com
• Phone: 972-999-2070

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.