Autologous Fat Grafting to the Face With Use of the Viality™ System

Status unconfirmed · Not applicable

Conditions studied: Adipose Tissue

In brief

The purpose of this research is to collect data on the short and long-term effects of facial fat grafting by injectable tissue replacement and regeneration in the midfacial zone, with the use of the VialityTM system. The Viality system is a US Food and Drug Administration (FDA) cleared device.

Key facts

Study ID

NCT06169670

Run by

Tiger Biosciences, LLC.

People needed

20

Starts

2023-11-13

Expected to finish

2025-03-13

Last updated by the study team

2023-12-13

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female patients > 18 years and < 65 years of age.
• Patients undergoing an aesthetic fat grafting procedure to the face.
• Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
• Patients must be non-smokers.
• Patients with available/adequate harvest sites for fat grafting.
• Anticipated harvested fat volume between 60 and 100 cc.
• Anticipated fat injection volume 40-55 cc.
• Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in diet or lifestyle during the study.

You may not qualify if…

• Skin rash in the treatment area.
• Patients who smoke or use nicotine products.
• Patients with bleeding disorders or currently taking anticoagulants.
• Patients with history of trauma or surgery to the treatment area.
• Active, chronic, or recurrent infection.
• Compromised immune system.
• Hypersensitivity to analgesic agents.
• Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
• Untreated drug and/or alcohol abuse.
• Pregnant or breastfeeding.
• Any issue that, at the discretion of the investigator, would contra-indicate the patient's participation.
• Patients who do not wish to have the study area photographed.

Where it is running

• Faces Plus — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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