Adipose TissueNCT06169670
Autologous Fat Grafting to the Face With Use of the Viality™ System
A study testing Viality in people with Adipose Tissue, run by Tiger Biosciences, LLC. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue
- What is being tested?
- Viality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 13 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Faces Plus
San Diego, California, 92121
Steven Cohen, MD, 858-453-7224, scohen@facesplus.com
Jordan Wesson, BS, 6199812000, jwess1999@gmail.com
About this study
Official title: Prospective Evaluation of Autologous Fat Grafting to the Face With the Use of Viality™ in Processing of Lipoaspirate
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.
Read the 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.
- Conditions
- Adipose Tissue
- Being tested
- Viality
- Keywords
- fat transfer, Viality, Injectable Tissue Replacement and Regeneration, midfacial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VialityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Lipoaspirate with Viality | Experimental | Patient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system. Receives: Device: Viality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Fat Volume Retention
Facial fat volume retention after facial fat transfer using Viality system will be monitored over the course of year and retrospectively compared to facial fat volume retention after facial fat transfers using traditional fat processing.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start13 Nov 2023
- Primary completion13 Jan 2025 (estimated)
- Study completion13 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adipose TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiger Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Faces+
- Responsible party
- Principal investigator, Steven Cohen, Tiger Biosciences, LLC.
- Investigators
- Sara Saul, Study director, Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169670
- Sponsor's protocol ID
- VIAL-001
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Sponsor will also monitor the site at various intervals. Case Report Forms and Investigator Binders will be reviewed for current data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Autologous Fat Grafting to the Face With the Use of Viality™ in Processing of Lipoaspirate
- ClinicalTrials.gov ID
- NCT06169670
- Acronym / sponsor ID
- VIAL-001
- Conditions
- Adipose Tissue
- Keywords
- fat transfer, Viality, Injectable Tissue Replacement and Regeneration, midfacial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
- Collaborators
- Faces+
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 13 Jan 2025 (estimated)
- Study completion
- 13 Mar 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Lipoaspirate with Viality | Experimental | Device: VialityPatient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VialityViality 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. | Device | Patients Receiving Lipoaspirate with Viality |
Primary outcome
Facial Fat Volume Retention
Time frame: 12 months
Facial fat volume retention after facial fat transfer using Viality system will be monitored over the course of year and retrospectively compared to facial fat volume retention after facial fat transfers using traditional fat processing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Yes. The Sponsor will also monitor the site at various intervals. Case Report Forms and Investigator Binders will be reviewed for current data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Saul study director
Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viality in people with Adipose Tissue, run by Tiger Biosciences, LLC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Cohen, MD ((858) 453-7224, scohen@facesplus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Fat Volume Retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.