SNIP follow-on Case Series Using v3 Device

August 27, 2026 updated by: Europa Life Sciences Limited

SNIP 11 Case Series

Case series of infants with anterior ankyloglossia being treated by the Sublingual Neonatal Incision Platform device

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

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 Contact

Study Locations

  • United Kingdom
      • Royal Tunbridge Wells, United Kingdom
        • Tunbridge Wells Hospital Pembury
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kudzai Mugweni, MBChB MSc FRCPCH AFHEA

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

Collaborators

Medway NHS Foundation Trust

Investigators

  • Principal Investigator: Aung Soe, MBChB MSc FRCPCH AFHEA, 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 (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1356

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.

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