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

NCT06169670 | Unknown DMC FDA Device

• 1 other identifier: VIAL-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adipose Tissue

Keywords

fat transfer; Viality; Injectable Tissue Replacement and Regeneration; midfacial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients Receiving Lipoaspirate with Viality

EXPERIMENTAL

Patient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system.

Device: Viality

Interventions

Viality DEVICE

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.

Patients Receiving Lipoaspirate with Viality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patients who are not and do not plan to be pregnant or breastfeeding during the duration of the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead
• Faces+: collaborator

Study Sites (1)

Faces Plus

San Diego, California, 92121, United States

RECRUITING

Study Officials

• Sara Saul

  Coordinator

  STUDY DIRECTOR

Central Study Contacts

Steven Cohen, MD

CONTACT

(858) 453-7224; scohen@facesplus.com

Jordan Wesson, BS

CONTACT

6199812000; jwess1999@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: This is a single-center, prospective study enrolling patients undergoing an aesthetic fat grafting procedure to the face. A total of 20 patients will be enrolled in the study, all patients will receive lipoaspirate processed with Viality.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: November 13, 2023
• Primary Completion: January 13, 2025
• Study Completion: March 13, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The Sponsor will collect data once patients have been followed for 3 months, 6 months, and at the end of the 12 month follow-up period.
• Access Criteria: Investigators with permission from the Primary Investigator or the Sponsor will be granted access to patient files stored on a secured server.

Locations

US (1)