Not yet recruitingNAINTERVENTIONAL

SNIP follow-on Case Series Using v3 Device

This study is looking at a new way to treat 'tongue-tie' in babies. Tongue-tie, medically known as ankyloglossia, is when the small piece of skin connecting the underside of the tongue to the floor of the mouth is too short or tight. This can sometimes make it difficult for babies to feed properly. Doctors call the procedure to release this skin a 'frenectomy'. This study will test a new, specially designed device to perform this procedure. It's called a 'case series', which means a small group of babies with tongue-tie will be treated with this new device. The main goal is to see if the device is practical and works well in real-life situations. The study focuses on babies between one week and twelve weeks old who have a type of tongue-tie at the front of their mouth.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Europa Life Sciences Limited

Enrolment target

Start

01 Oct 2026

Estimated completion

31 Jan 2027

Ankyloglossia

What is this study about?

This study is about finding a better way to help babies who have a condition called 'tongue-tie', which doctors also call ankyloglossia. Tongue-tie happens when the small strip of skin that connects your tongue to the bottom of your mouth is shorter or tighter than it should be. For some babies, this can make it hard to breastfeed or bottle-feed effectively.

When a tongue-tie causes problems, doctors might suggest a small procedure to release it. This procedure is called a 'frenectomy'. It involves making a small cut to release the tight skin. This study is testing a brand-new device, specially made for babies, to perform this procedure more easily and safely. It's called the 'Sublingual Neonatal Incision Platform' (SNIP v3) device.

The main aim of this study is to see how well this new device works in practice. It's a 'case series', meaning a group of babies with tongue-tie will have their procedure done using this device. The researchers want to find out if it's a practical and effective tool for treating tongue-tie in infants, making the procedure as straightforward as possible for both babies and their families.

Key takeaways

This study tests a new device for treating tongue-tie in babies.
It's for babies aged 1 week to 12 weeks with anterior tongue-tie.
The new device aims to make the procedure easier and safer.
The study assesses how practical the device is in real situations.
Participation involves the procedure and follow-up checks.

Who may be eligible?

This study is looking for babies who have 'tongue-tie' that needs to be treated. Specifically, it's for babies who have what doctors call 'anterior ankyloglossia', which means the tongue-tie is at the front of the mouth and is causing problems that require a procedure.

Babies can join if they are between one week and twelve weeks old, and the study is open to both boys and girls.

However, some babies cannot take part. This includes babies who have other special conditions in their mouth that might make the tongue-tie procedure complicated. Also, babies with problems that stop their blood from clotting normally, or those with a weakened immune system, would not be able to participate for safety reasons.

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 at the front of their mouth?
Has a doctor said your baby's tongue-tie needs treatment?
Does your baby have any other mouth conditions that might complicate surgery?
Does your baby have any known blood clotting issues or a weak immune system?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will have their tongue-tie released using the new SNIP v3 device. The procedure itself is usually very quick. You would likely have a consultation with the medical team beforehand to discuss everything. After the procedure, there will be follow-up appointments to check how your baby is healing and feeding. The study will not involve any medication for your baby beyond what is standard care, such as pain relief if needed. The total duration of your baby's involvement would include the procedure and a few follow-up checks, likely over a few weeks, to ensure everything is healing well.

Potential risks and benefits

The potential benefit of taking part is that your baby will receive treatment for their tongue-tie using a new, potentially improved device, which could help with feeding. As with any medical procedure, there are potential risks, such as a small chance of bleeding, infection, or the tongue-tie returning. The medical team will discuss these with you in detail. You are free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

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

Common questions

What is 'tongue-tie'?

Tongue-tie is when the small piece of skin under the tongue is too short, which can restrict the tongue's movement and sometimes affect feeding.

What is a 'frenectomy'?

It's a quick procedure where a doctor makes a small cut to release the tight skin causing the tongue-tie.

Why a new device?

Researchers are testing a new device specifically designed for babies to make the tongue-tie release procedure potentially safer and easier.

Is my baby too old or too young?

This study is for babies between one week and twelve weeks old.

What if we change our mind?

You can withdraw your baby from the study at any time, and it won't affect their care.

How to find out more

Kusal Weerasinghe, MBBS, MSc, FRSPH

kusal.weerasinghe@nhs.net 00441634833793 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.