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

N/AActive Not RecruitingNCT07655895

Europa Life Sciences Limited6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Ankyloglossia

Interventions

Frenectomy of anterior ankylogossia using the novel deviceDEVICE

Patient treated using the novel device under study

Eligibility

Sex: ALLMin age: 1 WeekMax age: 12 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Anterior ankyloglossia requiring intervention Exclusion Criteria: * Concomitant morphological variation in the oral cavity which could compromise frenectomy Blood dyscrasia Immunocompromise

Locations (1)

Tunbridge Wells Hospital Pembury

Royal Tunbridge Wells, United Kingdom

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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