NCT06034522
Active, not recruiting
Not Applicable
A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects
Volumina Medical S.A.1 site in 1 country18 target enrollmentStarted: November 25, 2023Last updated:
ConditionsMid-face Volume Deficiency
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Volumina Medical S.A.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety of Investigational Medical Device
Overview
Brief Summary
Adipearl is an injectable filler intended to be injected subcutaneously in the face.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Safety of Investigational Medical Device
Time Frame: Up to 6 months
Collection of Injection Site Reactions and Adverse Events during the study.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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