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Active, not recruitingNCT07655895SNIPUpdated Jun 18, 2026

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

An interventional study of Frenectomy of anterior ankylogossia using the novel device in Ankyloglossia, sponsored by Europa Life Sciences Limited. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 1 Week to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Europa Life Sciences Limited · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
1 Week to 12 Weeks
Sex
All
01

Study summary

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

02

Conditions studied

  • Ankyloglossia

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Keywords

  • Anterior
  • Infant
  • Novel device
  • Case Series
03

In context

Ankyloglossia

32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.

This study's planned enrollment of 6 is below the median of 105 across 22 interventional studies indexed under Ankyloglossia.

Browse Ankyloglossia studies →

Lead sponsor

Europa Life Sciences Limited is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Anterior ankyloglossia requiring intervention

Exclusion criteria

Exclusion Criteria:

  • Concomitant morphological variation in the oral cavity which could compromise frenectomy Blood dyscrasia Immunocompromise
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Infant with anterior ankyloglossia requiring intervention

    Patient is treated using the novel device

    Device: Frenectomy of anterior ankylogossia using the novel device

  • No intervention
    Non-treatment

    Patients identified as not requiring frenectomy

Interventions

  • DeviceFrenectomy of anterior ankylogossia using the novel device

    Patient treated using the novel device under study

    Also known as: Treatment with SNIP device

06

What researchers measure

Primary outcomes

  1. Clinician Device Experience

    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?

    Time frame: Immediately post-op

Secondary outcomes

  1. Operator-perceived infant discomfort

    The physician will be asked to rate Operator-perceived infant discomfort in Likert scale of 1-10

    Time frame: Immediately post-op

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07655895
Lead sponsor
Europa Life Sciences Limited
Responsible party
Sponsor
First posted
Jun 18, 2026
Start date
Mar 10, 2026
Primary completion
Jun 20, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jun 18, 2026

Study contacts

Aung Soe
principal investigator · Medway NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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