Facial fat grafting using the Viality system
Prospective Evaluation of Autologous Fat Grafting to the Face With the Use of Viality™ in Processing of Lipoaspirate
This study is testing if a new way to transfer fat to the face using the Viality system can safely improve facial volume for people looking for aesthetic enhancement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Tiger Biosciences, LLC. Industry-sponsored |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06169670 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the short and long-term effects of facial fat grafting using the Viality™ system, which is designed for washing and filtering autologous adipose tissue. The procedure involves aspirating fat from one area of the body, processing it, and reinjecting it into the midfacial zone to enhance volume. The study will collect data on the efficacy and safety of this minimally invasive technique, which is FDA-cleared. Participants will undergo aesthetic fat grafting procedures while adhering to specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 65 who are undergoing aesthetic fat grafting to the face and can comply with study protocols.
Not a fit: Patients with skin issues in the treatment area, smokers, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the effectiveness and longevity of facial fat grafting procedures for aesthetic enhancement.
How similar studies have performed: Previous studies have shown positive outcomes with similar fat grafting techniques, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- Faces Plus — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Steven Cohen, MD
- Email: scohen@facesplus.com
- Phone: (858) 453-7224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.