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

June 13, 2026 updated by: Europa Life Sciences Limited

Sublingual Neonatal Incision Platform (SNIP) Case Series

A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Royal Tunbridge Wells, United Kingdom
        • Tunbridge Wells Hospital Pembury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Anterior ankyloglossia requiring intervention

Exclusion Criteria:

  • Concomitant morphological variation in the oral cavity which could compromise frenectomy Blood dyscrasia Immunocompromise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infant with anterior ankyloglossia requiring intervention
Patient is treated using the novel device
Device: Frenectomy of anterior ankylogossia using the novel device
Patient treated using the novel device under study
Other Names:
  • Treatment with SNIP device
No Intervention: Non-treatment
Patients identified as not requiring frenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Device Experience
Time Frame: Immediately post-op
The physician will be asked to rate following attributes of the use of the tool, in Likert scale of 1-5; Whether the device felt intuitive, whether they felt more confident using this device, whether they would use this device again for a similar release?
Immediately post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator-perceived infant discomfort
Time Frame: Immediately post-op
The physician will be asked to rate Operator-perceived infant discomfort in Likert scale of 1-10
Immediately post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Europa Life Sciences Limited

Investigators

  • Principal Investigator: Aung Soe, Medway NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

June 13, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1355
  • 10100439 (Other Grant/Funding Number: Innovate UK)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankyloglossia

Clinical Trials on Frenectomy of anterior ankylogossia using the novel device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe