CompletedNot Applicable

Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume

Israel78 participantsStarted 2024-01-25

Plain-language summary

This study designed to evaluate the safety and performance of RefillHA Volume, a dermal filler for facial soft tissue augmentation and correction of facial wrinkles and folds in routine clinical setting.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult men and women, over the age of 18, seeking correction of facial wrinkles and folds and/or soft tissue augmentation. * Subjects who are willing and able to read, understand and sign informed consent. Exclusion Criteria: * Subjects with known contraindications to the treatment (as per device IFU). * Subjects considered to be unsuitable to participate, in the investigator's opinion, for any reason.

What they're measuring

1. The frequency of reported adverse events (number of participants who experienced each reported adverse event). 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe)

Timeframe: Up to 56 weeks after treatment

Trial details

NCT IDNCT07329608

SponsorGlyance

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-22

View on ClinicalTrials.gov More Wrinkles trials