NCT07796165

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Oct 2026Jan 2027

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 27, 2026

Last Update Submit

September 2, 2026

Conditions

Ankyloglossia

Keywords

InfantAnteriorPosteriorNovel DeviceCase Series

Outcome Measures

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?

    Immediately post-op

Secondary Outcomes (1)

  • Operator-perceived infant discomfort

    Immediately post-op

Study Arms (2)

Infant with ankyloglossia requiring intervention

EXPERIMENTAL

Patient is treated using the novel device

Device: Frenectomy of anterior ankylogossia using the novel device

Non-treatment

NO INTERVENTION

Patient identified as not requiring frenotomy

Interventions

Frenectomy of anterior ankylogossia using the novel deviceDEVICE

Patient treated using the novel device under study

Also known as: Treatment with SNIP device
Infant with ankyloglossia requiring intervention

Eligibility Criteria

Age1 Week - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ankyloglossia requiring intervention

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunbridge Wells Hospital Pembury

Royal Tunbridge Wells, United Kingdom

Location

MeSH Terms

Conditions

Ankyloglossia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Aung Soe, MBChB MSc FRCPCH AFHEA

    Medway NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kusal Weerasinghe, MBBS, MSc, FRSPH

CONTACT

00441634833793kusal.weerasinghe@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

September 4, 2026

Record last verified: 2026-08

Locations

GB(1)