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

December 5, 2023 updated by: Steven Cohen, Sientra, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Receiving Lipoaspirate with Viality
Patient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial Fat Volume Retention
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sientra, Inc.

Collaborators

Faces+

Investigators

  • Study Director: Sara Saul, Coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Estimated)

January 13, 2025

Study Completion (Estimated)

March 13, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIAL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Sponsor will also monitor the site at various intervals. Case Report Forms and Investigator Binders will be reviewed for current data.

IPD Sharing 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.

IPD Sharing Access Criteria

Investigators with permission from the Primary Investigator or the Sponsor will be granted access to patient files stored on a secured server.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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