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NCT Number: NCT07796165

SNIP follow-on Case Series Using v3 Device

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

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Key information

Conditions

Ankyloglossia Stomatognathic Diseases

Age range

1 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anterior ankyloglossia requiring intervention

Exclusion criteria

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

Treatment and study plan

Frenectomy of anterior ankylogossia using the novel device

Device

Patient treated using the novel device under study

Other names: Treatment with SNIP device

Primary outcomes

  1. 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?

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kusal Weerasinghe, MBBS, MSc, FRSPH

CONTACT

[email protected]

00441634833793

Sponsors and collaborators

Lead sponsor

Europa Life Sciences Limited

Industry

Collaborators

  • Medway NHS Foundation Trust

Registry information

Official study title

SNIP 11 Case Series

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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