Otitis MediaNCT07625657
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
A study testing CLiKX® Tympanostomy Tube Delivery System in people with Otitis Media and Otitis Media Chronic, run by ClinQure, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Otitis Media, Otitis Media Chronic, Otitis Media Effusion
- What is being tested?
- CLiKX® Tympanostomy Tube Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jul 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Texas Children's Hospital - West Campus
Houston, Texas, 77030
Sadaf Batla, 832-227-1583, Sadaf.Batla@bcm.edu
Sonal Saraiya, MD
- Recruiting
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, 40220
Certified Clinical Research Coordinator, (502) 399-1884, ddavis@advancedentandallergy.com
Clinical Research Manager, (502) 399-1874, jleonard@advancedentandallergy.com
- Recruiting
Clinical Investigations of Texas
Mesquite, Texas, 75150
Clinical Research Coordinator, (972) 599-1530, DeZaria.kidd@citplano.com
Clinical Research Coordinator, (972) 599-1530, alaafia.vaz@citplano.com
- Not yet recruiting
Texas Children's Hospital - Woodlands Campus
The Woodlands, Texas, 77384
Debra Canter, 832-824-7391, debra.canter@bcm.edu
Sonal Saraiya, MD
About this study
Official title: A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes
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.
Read more
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..
Read the detailed description
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.
- Conditions
- Otitis Media, Otitis Media Chronic, Otitis Media Effusion, Otitis Media Recurrent, Otitis Media in Children
- Being tested
- CLiKX® Tympanostomy Tube Delivery System
- Keywords
- otitis media, Tympanostomy tube, NousQ, CLiKX, myringotomy
- Medical subject headings
- Otitis Media, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLiKX® Tympanostomy Tube Delivery SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Tympanostomy Tube Treatment | Experimental | Subjects undergoing myringotomy with tympanostomy tube placement Receives: Device: CLiKX® Tympanostomy Tube Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At time of procedure (first or second attempt)
Secondary outcomes (5)
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.
Measured: ≤ 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
Measured: ≤ 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
Measured: ≤ 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:
- = Strongly Disagree
- = Disagree
- = Neutral
- = Agree
- = Strongly Agree
Higher scores indicate greater procedure satisfaction and acceptability.
Measured: ≤ 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
Measured: ≤ 1.0 hour after completion of the tympanostomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start7 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinQure, Inc.
- Sponsor type
- Research network
- Collaborators
- NousQ Pte Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625657
- Sponsor's protocol ID
- DDP-001-043P
- Other IDs
- CKX-001
- Status last verified
- Nov 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes
- ClinicalTrials.gov ID
- NCT07625657
- Acronym / sponsor ID
- DDP-001-043P
- Conditions
- Otitis Media, Otitis Media Chronic, Otitis Media Effusion, Otitis Media Recurrent, Otitis Media in Children
- Keywords
- otitis media, Tympanostomy tube, NousQ, CLiKX, myringotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ClinQure, Inc.Research network
- Collaborators
- NousQ Pte Ltd
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tympanostomy Tube Treatment | Experimental | Device: CLiKX® Tympanostomy Tube Delivery SystemSubjects undergoing myringotomy with tympanostomy tube placement |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLiKX® Tympanostomy Tube Delivery SystemThe 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. | Device | Tympanostomy Tube Treatment |
Primary outcome
Effectiveness of C-TTDS for tympanostomy tube placement
Time frame: At time of procedure (first or second attempt)
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
Time frame: At time of procedure (first or second attempt)
Safety will be assessed by incidence, severity and relatedness of device related adverse events occurring during the overall procedure.
5 secondary outcomes
FLACC Pain Scale
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
FPS-R
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
NRS Pain Scale
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure at the Post-Tympanostomy Procedure Visit
Caregiver Satisfaction Survey
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure
Physician Procedure Tolerability Evaluation
Time frame: ≤ 1.0 hour after completion of the tympanostomy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Active, not recruiting
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLiKX® Tympanostomy Tube Delivery System in people with Otitis Media and Otitis Media Chronic, run by ClinQure, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal George (972-999-2070, crystal@clinqure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of C-TTDS for tympanostomy tube placement (time frame: At time of procedure (first or second attempt)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.