NCT07655895

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 7, 2026

Last Update Submit

June 13, 2026

Conditions

Ankyloglossia

Keywords

AnteriorInfantNovel 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 anterior ankyloglossia requiring intervention

EXPERIMENTAL

Patient is treated using the novel device

Device: Frenectomy of anterior ankylogossia using the novel device

Non-treatment

NO INTERVENTION

Patients identified as not requiring frenectomy

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 anterior ankyloglossia requiring intervention

Eligibility Criteria

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

You may qualify if:

  • Anterior ankyloglossia requiring intervention

You may not qualify if:

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

    Medway NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

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

May 7, 2026

First Posted

June 18, 2026

Study Start

March 10, 2026

Primary Completion

June 20, 2026

Study Completion

July 1, 2026

Last Updated

June 18, 2026

Record last verified: 2026-05

Locations

GB(1)