Evaluation of Safety of Filler Injection in Subcutaneous Tissues

N/AActive Not RecruitingNCT06322043

Volumina Medical S.A.18 enrolled

Overview

Adipearl is an injectable filler intended to be injected subcutaneously.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Face Volume Deficiency

Interventions

AdipearlDEVICE

Injection of the investigational device in subcutaneous tissue.

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)

Summit Clinic

Crans-Montana, Switzerland

Outcomes

Primary Outcomes

Safety of Investigational Medical Device

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

Time frame: 6-Months

Data from ClinicalTrials.gov

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