Recruiting

Autologous Fat Grafting

Sponsor:

Tiger Biosciences, LLC.

Code:

NCT06169670

Conditions

Adipose Tissue

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Viality

Study Details

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

Study ID

NCT06169670

Start date

Nov 13, 2023

Status verified date

Dec, 2023

Completion date

Mar 13, 2025

Anticipated

Primary completion date

Jan 13, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients Receiving Lipoaspirate with Viality

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

Interventions

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.

Primary outcome measure

  • Facial Fat Volume Retention [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Steven Cohen, MD

(858) 453-7224scohen@facesplus.com

Jordan Wesson, BS

6199812000jwess1999@gmail.com

Locations

Faces Plus

Recruiting

San Diego, California, United States, 92121

Contacts

Steven Cohen, MD

858-453-7224scohen@facesplus.com

Jordan Wesson, BS

6199812000jwess1999@gmail.com

More Information

Sponsor

Tiger Biosciences, LLC.

Last update posted

Dec 13, 2023

Last verified

Dec, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tiger Biosciences, LLC. on 2023-12-13.