Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

N/AActive Not RecruitingNCT06034522

Volumina Medical S.A.18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Mid-face Volume Deficiency

Interventions

AdipearlDEVICE

Injection of the investigational device in the face.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Art Clinic

Stockholm, Sweden

Outcomes

Primary Outcomes

Safety of Investigational Medical Device

Collection of Injection Site Reactions and Adverse Events during the study.

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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