Ankyloglossia
Conditions
Keywords
Infant, Anterior, Posterior, Novel Device, Case Series
Brief summary
Case series of infants with anterior ankyloglossia being treated by the Sublingual Neonatal Incision Platform device
Detailed description
A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.
Interventions
Patient treated using the novel device under study
Sponsors
Europa Life Sciences Limited
Medway NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* Ankyloglossia requiring intervention
Exclusion criteria
* Concomitant morphological variation in the oral cavity which could compromise frenotomy * Blood dyscrasia * Immunocompromise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Device Experience | 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
| Measure | Time frame | Description |
|---|---|---|
| Operator-perceived infant discomfort | Immediately post-op | The physician will be asked to rate Operator-perceived infant discomfort in Likert scale of 1-10 |
Countries
United Kingdom
Contacts
CONTACTKusal Weerasinghe, MBBS, MSc, FRSPH
PRINCIPAL_INVESTIGATORAung Soe, MBChB MSc FRCPCH AFHEA
Medway NHS Foundation Trust
Outcome results
None listed