Clinical trial NCT06169670: Autologous Fat Grafting to the Face With Use of the Viality™ System
Official title: Prospective Evaluation of Autologous Fat Grafting to the Face With the Use of Viality™ in Processing of Lipoaspirate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adipose Tissue
Keywords: fat transfer
Viality
Injectable Tissue Replacement and Regeneration
midfacial
Lead sponsor: Tiger Biosciences, LLC.
Sponsor class: INDUSTRY
Collaborators: name: Faces+
First posted: 2023-12-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center, prospective study enrolling patients undergoing an aesthetic fat grafting procedure to the face. A total of 20 patients will be enrolled in the study, all patients will receive lipoaspirate processed with Viality.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial Fat Volume Retention
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Faces Plus
state: California
Study officials:
affiliation: Coordinator
name: Sara Saul
role: STUDY_DIRECTOR
References: