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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
ClinQure, Inc.
Study ID
NCT07625657
Status
Recruiting
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Conditions

  • Otitis Media
  • Otitis Media Chronic
  • Otitis Media Effusion
  • Otitis Media Recurrent
  • Otitis Media in Children

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLiKX® Tympanostomy Tube Delivery System — DEVICE
    The CLiKX device is an automated, sensor-optimized, partially reusable handheld surgical device used for tympanostomy tube placement. It consists of multiple components assembled before use and disassembled after the procedure. The device includes integrated, pre-programmed software that controls its mechanical actions. The software is locked, cannot be modified by users, and does not perform diagnostic or therapeutic decision-making. Instead, it provides visual cues and applies controlled force to assist the procedure. Compared to manual techniques, the CLiKX device automates key steps, including creating a precise slit incision using regulated force. This approach is designed to reduce operator variability, minimize trauma to the tympanic membrane, and improve accuracy of tube placement. Clinicians retain full control over targeting throughout the procedure.

Study Details

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 Dates

First listed
Jun 4, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tympanostomy Tube Treatment
    Subjects undergoing myringotomy with tympanostomy tube placement

Primary Outcome Measure

Effectiveness of C-TTDS for tympanostomy tube placement [ Time Frame: At time of procedure (first or second attempt) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Advanced ENT and Allergy, PLLCLouisvilleKentucky40220
Certified Clinical Research Coordinator
[email protected]
(502) 399-1884
Clinical Research Manager
[email protected]
(502) 399-1874
Steven Shotts, MD (PRINCIPAL_INVESTIGATOR)
Clinical Investigations of TexasMesquiteTexas75150-

Find similar trials in Louisville, KY

By research site
Advanced ENT and Allergy, PLLC· Louisville, KYClinical Investigations of Texas· Mesquite, TX

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