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

NCT07625657 | Recruiting

• 2 other identifiers: DDP-001-043PCKX-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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..

Conditions

Otitis Media; Otitis Media Effusion; Otitis Media Recurrent; Otitis Media in Children; Otitis Media Chronic

Keywords

otitis media; Tympanostomy tube; NousQ; CLiKX; myringotomy

Outcome Measures

Primary Outcomes (2)

• Effectiveness of C-TTDS for tympanostomy tube placement

  Effectiveness will be determined by success at the end of each ear tube procedure. Effectiveness is defined as the successful incision in the tympanic membrane and delivery of tympanostomy tube across the tympanic membrane in the proper position after a maximum of 2 insertion attempts per indicated ear. An insertion attempt is defined as an incision in the tympanic membrane by the C-TTDS

  At time of procedure (first or second attempt)

• Safety of C-TTDS for tympanostomy tube placement

  Safety will be assessed by incidence, severity and relatedness of device related adverse events occurring during the overall procedure.

  At time of procedure (first or second attempt)

Secondary Outcomes (5)

• FLACC Pain Scale

  ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit

• FPS-R

  ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit

• NRS Pain Scale

  ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit

• Caregiver Satisfaction Survey

  ≤ 1.0 hour after completion of the tympanostomy procedure

• Physician Procedure Tolerability Evaluation

  ≤ 1.0 hour after completion of the tympanostomy procedure

Study Arms (1)

Tympanostomy Tube Treatment

EXPERIMENTAL

Subjects undergoing myringotomy with tympanostomy tube placement

Device: CLiKX® Tympanostomy Tube Delivery System

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.

Tympanostomy Tube Treatment

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ClinQure, Inc.: lead
• NousQ Pte Ltd: collaborator

Study Sites (2)

Advanced ENT and Allergy, PLLC

Louisville, Kentucky, 40220, United States

RECRUITING

Clinical Investigations of Texas

Mesquite, Texas, 75150, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Otitis Media; Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Crystal George

CONTACT

972-999-2070; crystal@clinqure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)