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New ear tube robot could make surgery quicker and safer for kids

NCT ID NCT07625657

Disease control Sponsor: ClinQure, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a new handheld device called CLiKX that helps doctors place ear tubes in children and adults with chronic ear infections or fluid buildup. The device uses sensors and controlled force to make the procedure more precise. Researchers will check if the tube is placed correctly, how well patients tolerate it, and track any side effects for up to 30 days after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CLiKX Tympanostomy Tube Delivery System (a handheld surgical device)
What this could lead to
If successful, this device could make ear tube placement faster, more precise, and possibly less painful for patients.
What could go wrong
This is an early-stage study with only 80 participants, so results may not apply to everyone. The device is new, and there may be unexpected side effects or failures during tube placement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is scheduled to undergo tympanostomy tube insertion. 2. Subject is ≥ 6 months old at the time of informed consent. 3. Subject has an ear canal diameter of ≥ 4 mm. 4. 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). Exclusion Criteria: 1. Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice. 2. Subjects with known adverse reaction to anesthesia. 3. Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane. 4. Subjects with otitis externa. 5. Subjects with active acute otitis media. 6. Subjects with an ear canal diameter \< 4 mm. 7. Ear drums that are overly vertical or horizontal 8. Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator. 9. Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk. 10. Subjects with suspected middle ear tumors or vascular lesions. 11. Subjects diagnosed with acute sensorial hearing loss 12. Subjects with a history of surgery involving the ear drum. 13. Subjects with hemotympanum. 14. Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

chronic otitis media otitis media otitis media with effusion otitis media, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Otitis media Otitis media chronic Otitis media effusion Otitis media in children Otitis media recurrent

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced ENT and Allergy, PLLC

    RECRUITING

    Louisville, Kentucky, 40220, United States

  • Clinical Investigations of Texas

    RECRUITING

    Mesquite, Texas, 75150, United States

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