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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glyance Ltd

Lod, 7152026, Israel

About this study

This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume upon its launch, from patients treated with the product in a routine clinical setting of treatments.

In this study, patients seeking correction of facial wrinkles and folds and/or soft tissue augmentation who are candidates for treatment with RefillHA Volume according to its approved use will be offered to participate in the study. Eligible patients who are willing to participate in the study, after signing an informed consent, will be treated with RefillHA Volume in the facial regions where correction is requested, subject to the advice of the treating physician and in accordance with the approved use.

After recieving initial treatment, participants will attend 2 to 4 in-clinic follow-up visits, during which they were eligible to receive additional treatment with RefillHA Volume (up to two additional treatments during the follow-up period) if, per treating investigator's opinion, additional treatment is required for better correction or to maintain the results.

Clinical data were collected at all in clinic visits, including standardized facial photographs, pain perception self-assessement was recorded by subjects immediately after treatment. All subjects were asked for details of any Adverse Events (AEs) they had experienced. Subjects were asked to rate aesthetic results and Patient Satisfaction questionnaire at each follow-up visit. Physicians were asked to rate aesthetic results as well and details of the treatment session were recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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)

Time frame: Up to 56 weeks after treatment

Sponsors and collaborators

Lead sponsor

Glyance

Industry

Registry information

Official study title

A Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume, a Dermal Filler for Facial Soft Tissue Augmentation and Correction of Facial Wrinkles and Folds.

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jan 9, 2026
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed