Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects

Adipearl is an injectable filler intended to be injected subcutaneously in the face.

Study Overview

• Status: Active, not recruiting
• Conditions: Mid-face Volume Deficiency
• Intervention / Treatment: Device: Adipearl

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Art Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject having given freely and expressly informed consent;
• Subject deemed by the Investigator to be medically fit for injection of the product;
• Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria:

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject participating to another research study.
• Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face correction with Investigational device; Subjects will be injected with the investigational device in the face.	Device: Adipearl; Injection of the investigational device in the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Investigational Medical Device	Collection of Injection Site Reactions and Adverse Events during the study.	Up to 6 months

Collaborators and Investigators

• Sponsor: Volumina Medical S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DOC0478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No