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New tool aims to make Tongue-Tie release easier on babies

NCT ID NCT07655895

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new device called SNIP designed to treat tongue-tie in infants. The device is used to perform a frenectomy, a procedure that releases the tight band under the tongue. The study includes 6 infants with anterior tongue-tie and focuses on how easy the device is for doctors to use and how comfortable it is for the baby.

What this could mean

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

Active substance
SNIP device (a novel surgical tool for frenectomy)
What this could lead to
If successful, this device could make tongue-tie release procedures simpler and more comfortable for infants.
What could go wrong
This is a very small early study with only 6 infants, so results may not apply broadly. The device is new and unproven.

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.

Started

Mar 2026

Expected to finish

Jul 2026

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: * Anterior ankyloglossia requiring intervention Exclusion Criteria: * Concomitant morphological variation in the oral cavity which could compromise frenectomy 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

Contacts and locations

Locations

  • Tunbridge Wells Hospital Pembury

    Royal Tunbridge Wells, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.