Evaluation of Safety of Filler Injection in Subcutaneous Tissues

March 13, 2024 updated by: Volumina Medical S.A.

A Single-Arm Pilot Study to Evaluate the Safety of Adipearl Injection in the Subcutaneous Tissues of Adults

Adipearl is an injectable filler intended to be injected subcutaneously.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Crans-Montana, Switzerland
        • Summit Clinic
        • Contact:
          • Summit Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volume correction with Investigational Device
Subjects will be injected subcutaneously with the Investigational Device to correct volume deficiencies.
Device: Adipearl
Injection of the investigational device in subcutaneous tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Investigational Medical Device
Time Frame: 6-Months
Collection of Injection Site Reactions and Adverse Events during the study.
6-Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volumina Medical S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VM-APFB-1023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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