SNIP follow-on Case Series Using v3 Device

ConditionAnkyloglossia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-12

SponsorEuropa Life Sciences Limited

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ankyloglossia requiring intervention

Disqualifiers

Concomitant morphological variation in the oral cavity which could compromise frenotomy

Blood dyscrasia

Immunocompromise

Trial design

Design model

Single group

Treatments tested in this trial

Frenectomy of anterior ankylogossia using the novel device
Device
Patient treated using the novel device under study

Treatment groups

6 Participants

are divided into 2 treatment groups

Group A: Infant with ankyloglossia requiring interventionExperimental treatment 1 intervention

Group B: Non-treatmentNo intervention 0 interventions

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Europa Life Sciences Limited

Lead sponsor

Medway NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: