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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adipose Tissue

• NCT number: NCT06169670
• Study type: Interventional
• Source: Sientra, Inc.
• Contact: Steven Cohen, MD
• Phone: (858) 453-7224
• Email: scohen@facesplus.com
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Completion date: March 13, 2025