Active not recruitingNAINTERVENTIONAL

Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device

This research is investigating a brand new device specifically designed to help babies with a common condition called tongue-tie (anterior ankyloglossia). Tongue-tie can sometimes make it difficult for babies to feed properly. The study wants to find out if this new device is practical and safe to use for a small operation called a frenectomy, which releases the tongue. It's focused on young infants, between one week and twelve weeks old, to see if this new approach could be a good way to treat the condition and improve their feeding.

At a glance

Status

Active not recruiting

Phase

Sponsor

Europa Life Sciences Limited

Enrolment target

Start

10 Mar 2026

Estimated completion

01 Jul 2026

Ankyloglossia

What is this study about?

This research is all about helping babies who have something called a 'tongue-tie'. Imagine a small piece of skin under the tongue that's a bit too tight, limiting how much the tongue can move. This is known as anterior ankyloglossia, and for some babies, it can make feeding, especially breastfeeding, quite challenging. Doctors often treat this with a simple procedure called a frenectomy, where this small piece of skin is carefully released.

This particular study is exciting because it's looking at a brand new, special device designed just for this procedure in babies. The main goal is to see if this new tool makes the frenectomy easier, safer, and more effective for very young infants.

This kind of research is really important because it helps doctors find better ways to care for babies. If this new device works well, it could potentially improve how babies with tongue-tie are treated in the future, helping them feed better and grow healthier.

Key takeaways

New device for treating tongue-tie in babies.
Aims to make tongue-tie procedure easier and safer.
For babies 1 week to 12 weeks old.
Could help improve feeding difficulties.
Looks at practicality and safety of the new tool.

Who may be eligible?

This study is looking for very young babies, specifically between one week and twelve weeks old.

Your baby might be able to join if they have a tongue-tie (anterior ankyloglossia) that a doctor believes needs treating. However, they won't be able to take part if they have other mouth conditions that might make the procedure difficult, or if they have certain blood conditions or problems with their immune system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby between 1 week and 12 weeks old?
Does your baby have a tongue-tie that a doctor says needs treatment?
Does your baby NOT have any other unusual mouth conditions?
Does your baby NOT have any known blood clotting problems?
Does your baby NOT have any known immune system problems?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they would receive the tongue-tie treatment using the new device. The study is mainly focused on checking if the device works well and is safe during the procedure itself. We don't have details on specific follow-up visits or tests, but typically after a tongue-tie procedure, doctors will want to check how your baby is recovering and feeding in the days and weeks afterwards. The total duration of active participation would likely be short, around the time of the procedure itself, with follow-up as decided by your doctor.

Potential risks and benefits

Potential benefits for your baby include receiving treatment for their tongue-tie, which could help with feeding difficulties. They would also be helping doctors learn more about a new treatment option that could benefit other babies in the future. Potential risks are generally low for this type of procedure but can include minor bleeding, infection, or discomfort, as with any medical intervention. However, the study aims to assess the safety of the new device itself. Remember, you can always change your mind and withdraw your baby from the study at any time without affecting their medical care.

Locations (1)

Tunbridge Wells Hospital Pembury
Verified postcode
Royal Tunbridge Wells, United Kingdom

Common questions

What is a 'tongue-tie'?

A tongue-tie is when the small piece of skin under a baby's tongue is too short or tight, which can limit tongue movement.

Why is it important to treat a tongue-tie?

For some babies, a tongue-tie can make feeding difficult, especially breastfeeding, preventing them from latching properly.

What is a frenectomy?

A frenectomy is a quick, simple procedure to carefully release the tight piece of skin under the tongue.

Will this new device hurt my baby?

The study aims to assess if the new device performs the procedure safely and with minimal discomfort, similar to current methods.

Can all babies with tongue-tie join this study?

No, there are specific age limits (1 week to 12 weeks old) and certain health conditions that would prevent a baby from joining.