AnkyloglossiaNCT07796165
SNIP follow-on Case Series Using v3 Device
A study testing Frenectomy of anterior ankylogossia using the novel device in people with Ankyloglossia, run by Europa Life Sciences Limited at 1 site in United Kingdom.
Trial summary
Case series of infants with anterior ankyloglossia being treated by the Sublingual Neonatal Incision Platform device Read more about this study
- Who is it for?
- Ages 1 week to 12 weeks
- Conditions the study is for
- Ankyloglossia
- What is being tested?
- Frenectomy of anterior ankylogossia using the novel device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ankyloglossia requiring intervention
Who cannot join
- Concomitant morphological variation in the oral cavity which could compromise frenotomy
- Blood dyscrasia
- Immunocompromise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Tunbridge Wells Hospital Pembury
Royal Tunbridge Wells
Neonatal & Children's Research Nurse, 00441892638641, elizabeth.day5@nhs.net
Children's Research Team, 00441892638641, mtw-tr.childrens-research@nhs.net
About this study
Official title: SNIP 2 Case Series
Case series of infants with anterior ankyloglossia being treated by the Sublingual Neonatal Incision Platform device
Read the detailed description
A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.
- Conditions
- Ankyloglossia
- Being tested
- Frenectomy of anterior ankylogossia using the novel device
- Keywords
- Infant, Anterior, Posterior, Novel Device, Case Series
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frenectomy of anterior ankylogossia using the novel deviceDevice
Also called Treatment with SNIP device
Patient treated using the novel device under study
| Study group | Role | What they receive |
|---|---|---|
| Infant with ankyloglossia requiring intervention | Experimental | Patient is treated using the novel device Receives: Device: Frenectomy of anterior ankylogossia using the novel device |
| Non-treatment | No intervention | Patient identified as not requiring frenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Immediately post-op
Secondary outcomes (1)
Operator-perceived infant discomfort
The physician will be asked to rate Operator-perceived infant discomfort in Likert scale of 1-10
Measured: Immediately post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Europa Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medway NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Aung Soe, MBChB MSc FRCPCH AFHEA, Principal investigator, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796165
- Sponsor's protocol ID
- 1356
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNIP 2 Case Series
- ClinicalTrials.gov ID
- NCT07796165
- Acronym / sponsor ID
- 1356
- Conditions
- Ankyloglossia
- Keywords
- Infant, Anterior, Posterior, Novel Device, Case Series
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Europa Life Sciences LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Medway NHS Foundation Trust
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant with ankyloglossia requiring intervention | Experimental | Device: Frenectomy of anterior ankylogossia using the novel devicePatient is treated using the novel device |
| Non-treatment | No intervention | –Patient identified as not requiring frenotomy |
Who may qualify
- Ages
- 1 week to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ankyloglossia requiring intervention
Key exclusion criteria (3 listed)
- Concomitant morphological variation in the oral cavity which could compromise frenotomy
- Blood dyscrasia
- Immunocompromise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frenectomy of anterior ankylogossia using the novel deviceAlso: Treatment with SNIP devicePatient treated using the novel device under study | Device | Infant with ankyloglossia requiring intervention |
Primary outcome
Clinician Device Experience
Time frame: 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?
1 secondary outcome
Operator-perceived infant discomfort
Time frame: Immediately post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Related trials for Ankyloglossia
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Ankyloglossia, Impairment of Speech
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Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
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Ankyloglossia and Breastfeeding
Ankyloglossia, Breastfeeding
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The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes
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Active, not recruiting
Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device
Ankyloglossia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aung Soe, MBChB MSc FRCPCH AFHEA principal investigator
Medway NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frenectomy of anterior ankylogossia using the novel device in people with Ankyloglossia, run by Europa Life Sciences Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kusal Weerasinghe, MBBS, MSc, FRSPH (00441634833793, kusal.weerasinghe@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Device Experience (time frame: Immediately post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.