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Can a new device make Tongue-Tie release easier and gentler?

NCT ID NCT07796165

Disease control Sponsor: Europa Life Sciences Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This case series tests a new device called the Sublingual Neonatal Incision Platform (SNIP) for releasing tongue-tie in infants. The study enrolls six infants with anterior ankyloglossia who need intervention. Clinicians will rate how intuitive the device feels and whether they would use it again, and they will also rate the infant's discomfort during the procedure. The goal is to see if this device offers a practical and comfortable option for this common procedure.

What this could mean

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

Active substance
A novel device called the Sublingual Neonatal Incision Platform (SNIP) used to perform a frenectomy (tongue-tie release) in infants
What this could lead to
If the device proves easy for clinicians to use and comfortable for infants, it could offer a simpler, more consistent way to perform tongue-tie releases.
What could go wrong
This is a very small case series with only six infants, so the results may not apply broadly. The device is new, and its safety and effectiveness are not yet established.

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 6 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 week to 12 weeks

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: * Ankyloglossia requiring intervention Exclusion Criteria: * Concomitant morphological variation in the oral cavity which could compromise frenotomy * Blood dyscrasia * Immunocompromise

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Conditions

The condition(s) this trial relates to.

ankyloglossia

As listed by the trial registrant

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

Ankyloglossia

How to take part

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

  1. The places running it

    1 site. 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

  • Tunbridge Wells Hospital Pembury

    Royal Tunbridge Wells, United Kingdom

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