RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-13
Study Completion:2025-03-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06169670

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patients \> 18 years and \< 65 years of age.
  2. * Patients undergoing an aesthetic fat grafting procedure to the face.
  3. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
  4. * Patients must be non-smokers.
  5. * Patients with available/adequate harvest sites for fat grafting.
  6. * Anticipated harvested fat volume between 60 and 100 cc.
  7. * Anticipated fat injection volume 40-55 cc.
  8. * Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in diet or lifestyle during the study.
  1. * Skin rash in the treatment area.
  2. * Patients who smoke or use nicotine products.
  3. * Patients with bleeding disorders or currently taking anticoagulants.
  4. * Patients with history of trauma or surgery to the treatment area.
  5. * Active, chronic, or recurrent infection.
  6. * Compromised immune system.
  7. * Hypersensitivity to analgesic agents.
  8. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
  9. * Untreated drug and/or alcohol abuse.
  10. * Pregnant or breastfeeding.
  11. * Any issue that, at the discretion of the investigator, would contra-indicate the patient's participation.
  12. * Patients who do not wish to have the study area photographed.

Contacts and Locations

Study Contact

Steven Cohen, MD
CONTACT
(858) 453-7224
scohen@facesplus.com
Jordan Wesson, BS
CONTACT
6199812000
jwess1999@gmail.com

Principal Investigator

Sara Saul
STUDY_DIRECTOR
Coordinator

Study Locations (Sites)

Faces Plus
San Diego, California, 92121
United States

Collaborators and Investigators

Sponsor: Sientra, Inc.

  • Sara Saul, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-11-13
Study Completion Date2025-03-13

Study Record Updates

Study Start Date2023-11-13
Study Completion Date2025-03-13

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Adipose Tissue