Can your own fat restore a youthful face? a new device puts it to the test
NCT ID NCT05522426
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial is testing whether a device called the SyntrFuge system can improve facial contouring by processing a person's own fat before it is injected into the face. The study enrolls adults aged 18 to 70 who have facial atrophy or loss of contour. Participants receive injections of their own processed fat, and the researchers measure satisfaction and aesthetic improvement using standardized questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SyntrFuge system, a device that processes a person's own fat for facial grafting
- What this could lead to
- If successful, this could offer a more effective way to restore facial volume and contour using a person's own fat, potentially improving satisfaction with facial appearance.
- What could go wrong
- This is an early, open-label study without a control group, so results may be biased. The procedure carries typical risks of fat grafting, such as swelling, bruising, or uneven results.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects aged of 18-70 years old 2. Willing and able to read and sign the informed consent and other study materials 3. Written informed consent has been obtained prior to any study-related procedures 4. Subjects are ambulatory 5. Ability to follow study instructions and complete study assessment tools including the subject diary 6. Females of childbearing potential must have a negative urine pregnancy test result and not be lactating 7. Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, any other permanent or semi-permanent facial fillers 1.5.2 Exclusion Criteria: 1. Subjects without decisional capacity 2. Subjects unable to give informed, written consent 3. Subjects with active infection (redness, swelling, pain, suppuration) 4. Subjects with any uncontrolled systemic disease 5. Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies 6. Subjects with conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma 7. Subjects planning to become pregnant, are pregnant, or are breast-feeding 8. Subjects with history or current evidence of drug or alcohol abuse within 12 months prior to screening visit 9. Subjects who have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. 10. Subjects who have undergone facial plastic surgery (except for rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study that may interfere with the study procedure and results 11. Subjects who have active autoimmune disease 12. Subjects who are unwilling to undergo fat graft injections 13. Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study 14. Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed 15. Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Newport Beach Site 1
Newport, California, 92660, United States
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Newport Beach Site 2
Newport Beach, California, 92660, United States