Status:
UNKNOWN
Autologous Fat Grafting to the Face With Use of the Viality™ System
Lead Sponsor:
Tiger Biosciences, LLC.
Collaborating Sponsors:
Faces+
Conditions:
Adipose Tissue
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 V...
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 tiss...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06169670
Start Date
November 13 2023
End Date
March 13 2025
Last Update
December 13 2023
Active Locations (1)
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1
Faces Plus
San Diego, California, United States, 92121