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Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

Sponsor
Volumina Medical S.A. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06034522
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
21
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Adipearl
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Face correction with Investigational device

Subjects will be injected with the investigational device in the face.

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

Outcome Measures

Primary Outcome Measures

  1. Safety of Investigational Medical Device [Up to 6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Art Clinic Stockholm Sweden

Sponsors and Collaborators

  • Volumina Medical S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Volumina Medical S.A.
ClinicalTrials.gov Identifier:
NCT06034522
Other Study ID Numbers:
  • DOC0478
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 13, 2023