An interventional study of CLiKX® Tympanostomy Tube Delivery System in Otitis Media, Otitis Media Chronic and Otitis Media Effusion, sponsored by ClinQure, Inc.. Recruiting at 4 sites in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by ClinQure, Inc. · Not applicable, Interventional, and Treatment
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..
This is a prospective, single-arm, multicenter study designed to evaluate the safety and effectiveness of the CLiKX device for the placement of tympanostomy tubes in pediatric and adult patients undergoing tympanostomy tube insertion for the treatment of chronic otitis media or other conditions requiring tympanostomy tube placement.
Eligible participants include children and adults ≥6 months of age who are scheduled to undergo tympanostomy tube insertion and have an ear canal diameter ≥4 mm.
The primary objective of the study is to evaluate procedural success (effectiveness), defined as successful incision of the tympanic membrane (myringotomy) and delivery of the tympanostomy tube into the intended position, while minimizing device-related adverse events during the procedure (safety).
Secondary objectives include the assessment of safety through 30 days post-procedure, as well as evaluation of procedural workflow and device performance.
Participants will complete study visits at the following time points: Baseline, Tympanostomy Procedure Visit, Post-Tympanostomy Procedure Visit (at discharge), and a 30-day Follow-Up Visit. Adverse events, concomitant medications, and procedural tolerability will be monitored throughout the study period.
This study is designed to support the intended use of the CLiKX device for performing myringotomy and facilitating delivery of tympanostomy tubes through the tympanic membrane in a clinical setting.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 80 is below the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →This is the only study on the registry with ClinQure, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects undergoing myringotomy with tympanostomy tube placement
Device: CLiKX® Tympanostomy Tube Delivery System
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.
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
Time frame: 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.
Time frame: At time of procedure (first or second attempt)
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.
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
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
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
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
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
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.
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure
Physician Procedure Tolerability Evaluation
Performing surgeon and anesthesiologist acceptability of subject tolerability of the procedure. Binary 'Yes' or 'No' response
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.
Of 36 non-industry interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 64. This study's planned 11 months is below that.
Counting every sponsor, half of 45 studies reached it within 38 months; a quarter within 13 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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