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A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma

NCT06565988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-03-27

No results posted yet for this study

Summary

A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region.

Conditions

  • Midface Volume Deficit

Interventions

DEVICE

Decoria Voluma

Decoria® Voluma medical device is a sterile, single use Hyaloronic acid based dermal filler intended for aesthetic use, provided in the form of a nonpyrogenic, viscoelastic gel. It is composed of highly purified sodium hyaluronate of high molecular weight, dissolved in a physiological buffer at pH 6.0-7.5. The sodium hyaluronate is derived from microbial fermentation and is stabilized by crosslinking with the chemical agent BDDE (1,4 Butanediol Diglycidyl Ether). Decoria® Voluma dermal fillers are injected into dermal tissue for the correction of midface volume deficit by tissue augmentation in cheek region, supporting overlying tissue to shape facial contours to desired level of correction. This is possible due to the capacity of HA to attract and bind large amounts of water, forming a viscous gel. Appropriate injection volume for the cheek region(s) will be determined by the Treating investigator according to IFU.

Sponsors & Collaborators

  • Key2Compliance

    collaborator INDUSTRY

  • Bohus Biotech AB

    lead INDUSTRY

Principal Investigators

  • Lucian Grema, M.D · Florakliniken, Stockholm, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2025-09-26
Completion
2025-09-26

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06565988 on ClinicalTrials.gov