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..
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).
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.
Single group
CLiKX® Tympanostomy Tube Delivery System
DeviceThe 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.
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
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.
FLACC Pain Scale
Face, Legs, Activity, Cry, and Consolability observational pain rating scalle for Infants and children less greater than or equal to 6 months to 5 years of age.
FPS-R
Faces Pain Rating Scale - Revised self-reporting pain rating scale for children greater than or equal to 5 to 7 years of age
NRS Pain Scale
11-point Number Rating Scale for Pain. Provided to children, adolescents, and adults greater than or equal to 7 years of age
Caregiver Satisfaction Survey
Procedure satisfaction and acceptability will be assessed using a subject-, parent-, guardian-, and/or caregiver-reported satisfaction survey evaluating procedure tolerability, satisfaction, perceived importance of alternatives to general anesthesia, perceived reduction in cost and procedure time, and willingness to recommend the procedure to others. Survey responses will be assessed using a 5-point Likert scale: 1. = Strongly Disagree 2. = Disagree 3. = Neutral 4. = Agree 5. = Strongly Agree Higher scores indicate greater procedure satisfaction and acceptability.
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ClinQure, Inc.
Lead sponsor
NousQ Pte Ltd
Collaborator
