Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

Mid-face Volume Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034522
• Other study ID #: DOC0478
• Status: Recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Volumina Medical S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mid-face Volume Deficiency

Intervention

Device:
• Adipearl
Injection of the investigational device in the face.

Locations

Country	Name	City	State
Sweden	Art Clinic	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Volumina Medical S.A.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Investigational Medical Device	Collection of Injection Site Reactions and Adverse Events during the study.	Up to 6 months