Autologous Fat Grafting to the Face With Use of the Viality™ System
NCT ID: NCT06169670
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-11-13
2025-03-13
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients Receiving Lipoaspirate with Viality
Patient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Faces+
OTHER
Tiger Biosciences, LLC.
INDUSTRY
Responsible Party
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Steven Cohen
Plastic Surgeon
Principal Investigators
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Sara Saul
Role: STUDY_DIRECTOR
Coordinator
Locations
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Faces Plus
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Steven Cohen, MD
Role: primary
Jordan Wesson, BS
Role: backup
Other Identifiers
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VIAL-001
Identifier Type: -
Identifier Source: org_study_id