Post Market Study of Safety and Performance of RefillHA Volume+ for Facial Soft Tissue Augmentation and Correction of Wrinkles and Folds

NCT07109635 | Completed

• 1 other identifier: PMCF-SP-200-02
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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 will be 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.

Conditions

Wrinkles Such as Nasolabial Folds

Keywords

wrinkles

Outcome Measures

Primary Outcomes (1)

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

  Up to 56 weeks after treatment

Study Arms (1)

Subjects over the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tiss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects over the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tissue augmentation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glyance: lead

Study Sites (1)

Glyance Ltd

Lod, 7152026, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: February 19, 2024
• Primary Completion: October 28, 2024
• Study Completion: May 18, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)