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OpenTrials
Active, Not Recruiting

NCT Number: NCT06034522

Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mid-face Volume Deficiency

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Art Clinic

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adipearl

Device

Injection of the investigational device in the face.

Primary outcomes

  1. Safety of Investigational Medical Device

    Time frame: Up to 6 months

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

Sponsors and collaborators

Lead sponsor

Volumina Medical S.A.

Industry

Registry information

Official study title

A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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