Evaluation of Safety of Filler Injection in Subcutaneous Tissues
Not Applicable
Not yet recruiting
- Conditions
- Volume Deficiency
- Interventions
- Device: Adipearl
- Registration Number
- NCT06322043
- Lead Sponsor
- Volumina Medical S.A.
- Brief Summary
Adipearl is an injectable filler intended to be injected subcutaneously.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Volume correction with Investigational Device Adipearl Subjects will be injected subcutaneously with the Investigational Device to correct volume deficiencies.
- Primary Outcome Measures
Name Time Method Safety of Investigational Medical Device 6-Months Collection of Injection Site Reactions and Adverse Events during the study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Summit Clinic
🇨🇭Crans-Montana, Switzerland