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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06034522
Enrollment
18
Registered
2023-09-13
Start date
2023-11-25
Completion date
2026-11-30
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mid-face Volume Deficiency

Brief summary

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

Interventions

DEVICEAdipearl

Injection of the investigational device in the face.

Sponsors

Volumina Medical S.A.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Safety of Investigational Medical DeviceUp to 6 monthsCollection of Injection Site Reactions and Adverse Events during the study.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026