Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

Not Applicable

Recruiting

• Conditions: Mid-face Volume Deficiency
• Interventions: Device: Adipearl

• Registration Number: NCT06034522
• Lead Sponsor: Volumina Medical S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-21
• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Face correction with Investigational device	Adipearl	Subjects will be injected with the investigational device in the face.

Primary Outcome Measures

Name	Time	Method
Safety of Investigational Medical Device	Up to 6 months	Collection of Injection Site Reactions and Adverse Events during the study.

Trial Locations

Locations (1)

Art Clinic; 🇸🇪 Stockholm, Sweden