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

Launched by TIGER BIOSCIENCES, LLC. · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a procedure called facial fat grafting, which involves taking fat from one part of the body and injecting it into the face to improve its appearance. The researchers are using a special device called the Viality™ system, which is approved by the FDA for this type of treatment. They want to understand both the short-term and long-term outcomes of this procedure, especially in the midface area.

To participate in this trial, you need to be a healthy woman aged between 18 and 65 who is planning to have facial fat grafting for cosmetic reasons. You'll also need to be a non-smoker and agree to keep your weight stable during the study. If you join, you can expect to undergo the fat grafting procedure and have regular follow-ups to monitor your progress. It’s important to know that there are specific health conditions that would exclude you from participating, such as having a skin rash in the treatment area or certain medical issues. If you're interested and meet the eligibility criteria, this trial could be a great opportunity to contribute to valuable research on facial rejuvenation techniques.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.