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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Adipose Tissue
Intervention / Treatment

-

Contacts and Locations

San Diego

Faces Plus, San Diego, California, United States, 92121

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Sientra, Inc.,

Sara Saul, STUDY_DIRECTOR, Coordinator

Study Record Dates

2025-03-13