Post-market follow-up for RefillHA Lips to fix mild lip defects
Official title: A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips.
Run by Glyance · NCT07831213 · Data updated 2026-11-12
This post-market study tests RefillHA Lips in adults to see how safely and effectively it remolds mild lip defects in real-world settings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 87 (estimated) |
| Sponsor | Glyance Industry-sponsored |
| Locations | 1 site (Lod, Israel) |
| Status | Recruiting |
| Started | January 18, 2024 |
| Main results expected | February 25, 2027 |
| Study ends | February 25, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07831213 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older seeking non-surgical lip augmentation with RefillHA Lips.
✕Probably not a fit
Patients with contraindications, recent dermal filler use, active infections, or uncontrolled conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-interventional follow-up of patients treated with RefillHA Lips in routine practice. Participants are adults who receive at least one injection and sign consent, with visits at 1, 3, 6, 9, and 12 months to monitor safety and performance. Clinicians document injection details and assess outcomes during each visit, reflecting standard care. No fixed treatment protocol is prescribed; practitioners decide indications, technique, and retreatment per usual care. The study aims to observe how the device performs in real-world use rather than to test a predefined hypothesis.
Why it matters
Potential benefit: If successful, the study could support the real-world safety and effectiveness of RefillHA Lips for correcting mild lip defects.
How similar studies have gone: Prior post-market observations have provided safety data for similar fillers, though results can vary by product and setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men or women of any race, 18 years of age or older. * Able to read, understand and sign informed consent. Exclusion Criteria: * Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU. * Patients with multiple and/or severe allergies or history of anaphylaxis. * Pregnant or lactating women (contraindications as per IFU). * Having received prior dermal filler injections in the six months preceding the study. * Previously treated with semi-permanent or permanent filler in the intended injection area. * Presenting with a cutaneous disorder, inflammation or infection near to the treatment area. * Known hypersensitivity to lidocaine and/or lidocaine HCl or hyaluronic acid. * Metabolic or endocrine uncontrolled disease, anaphylaxis, severe allergies or uncontrolled immune disorder. * Undergoing or planning to undergo peeling treatment or laser-/ultrasound-based treatment within 3 weeks before or after injection. * Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed. * Subject who has a condition or is in a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study or with protocol evaluation parameters.
Where it's running
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Glyance Ltd
Lod, Israel, Israel Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.