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

Adipose Tissue Clinical Trial

Official title:

Prospective Evaluation of Autologous Fat Grafting to the Face With the Use of Viality™ in Processing of Lipoaspirate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169670
• Other study ID #: VIAL-001
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: March 13, 2025

Study information

• Verified date: December 2023
• Source: Sientra, Inc.
• Contact: Steven Cohen, MD
• Phone: (858) 453-7224
• Email: scohen[@]facesplus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Autologous fat transfer (AFT) is a minimally invasive medical procedure that includes aspirating adipose tissue from one part of the body and washing, filtering, and reinjecting the processed fat tissue into a different part of the body with the primary purpose of adding volume.

A 2013 survey of the American Society of Plastic Surgeons indicated that 80% of the responding physicians use AFT.

Several published studies conclude that using a filter mesh to concentrate the fat by removing surgical tumescent fluid and blood improves fat graft retention (Salinas et al., Girard et al., Ansorge et.al.). Furthermore, washing and filtration of the autologous adipose tissue produces a fat graft with higher tissue viability (Zhu et al., Girard et al., Barbour et al.)

Viality is a lipoaspirate wash system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister.

Viality is to be used to filter and wash aspirated, harvested autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. Viality is not intended to process autologous adipose tissue other than for aesthetic body contouring uses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 13, 2025
• Est. primary completion date: January 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adipose Tissue

Intervention

Device:
• Viality
Viality is a lipoaspirate wash system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. Viality is to be used to filter and wash aspirated, harvested autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. Viality is not intended to process autologous adipose tissue other than for aesthetic body contouring uses.

Locations

Country	Name	City	State
United States	Faces Plus	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sientra, Inc.	Faces+

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial Fat Volume Retention	Facial fat volume retention after facial fat transfer using Viality system will be monitored over the course of year and retrospectively compared to facial fat volume retention after facial fat transfers using traditional fat processing.	12 months