Facial Atrophy and Loss of ContourNCT05522426
Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting
A study testing SyntrFuge System in people with Facial Atrophy and Loss of Contour, run by Syntr Health Technologies, Inc. at 2 sites in United States.
Trial summary
This is an open label multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in facial aesthetics and contouring. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Atrophy and Loss of Contour
- What is being tested?
- SyntrFuge System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged of 18-70 years old
- Willing and able to read and sign the informed consent and other study materials
- Written informed consent has been obtained prior to any study-related procedures
- Subjects are ambulatory
- Ability to follow study instructions and complete study assessment tools including the subject diary
- Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
Show all 23Show fewer
- 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:
- Subjects without decisional capacity
- Subjects unable to give informed, written consent
- Subjects with active infection (redness, swelling, pain, suppuration)
- Subjects with any uncontrolled systemic disease
- Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
- Subjects with conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma
- Subjects planning to become pregnant, are pregnant, or are breast-feeding
- Subjects with history or current evidence of drug or alcohol abuse within 12 months prior to screening visit
- 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.
- 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
- Subjects who have active autoimmune disease
- Subjects who are unwilling to undergo fat graft injections
- 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
- 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
- Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Newport Beach Site 1
Newport, California, 92660
Newport Beach Site 2
Newport Beach, California, 92660
About this study
This is an open label multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in facial aesthetics and contouring. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites.
- Conditions
- Facial Atrophy and Loss of Contour
- Being tested
- SyntrFuge System
- Keywords
- Microsized Fat Tissue, Adipose Tissue, Facial Contouring, Fat Transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntrFuge SystemDevice
Microsized Adipose Tissue
| Study group | Role | What they receive |
|---|---|---|
| SyntrFuge System | Experimental | Adipose tissue microsized via the SyntrFuge System Receives: Device: SyntrFuge System |
What is being measured
The primary outcome is the main question the study is designed to answer.
FaceQ Satisfaction surveys
Change from baseline in FACE-Q Satisfaction with questionnaire score for the treated regions
Measured: 6 months
Secondary outcomes (2)
Global Aesthetic Improvement Scale (GAIS)
Change in facial regions characteristics as measured by the Global Aesthetic Improvement Scale (GAIS) form from baseline
Measured: 6 months
Investigator's Satisfaction Scale
Change in facial regions characteristics as measured by the Investigator's Satisfaction Scale form from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Atrophy and Loss of ContourStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syntr Health Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522426
- Sponsor's protocol ID
- SHT-SYN-02
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting
- ClinicalTrials.gov ID
- NCT05522426
- Acronym / sponsor ID
- SHT-SYN-02
- Conditions
- Facial Atrophy and Loss of Contour
- Keywords
- Microsized Fat Tissue, Adipose Tissue, Facial Contouring, Fat Transfer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Syntr Health Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Aug 2022 (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.
This is an open label multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in facial aesthetics and contouring. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SyntrFuge System | Experimental | Device: SyntrFuge SystemAdipose tissue microsized via the SyntrFuge System |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects aged of 18-70 years old
- Willing and able to read and sign the informed consent and other study materials
- Written informed consent has been obtained prior to any study-related procedures
- Subjects are ambulatory
- Ability to follow study instructions and complete study assessment tools including the subject diary
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SyntrFuge SystemMicrosized Adipose Tissue | Device | SyntrFuge System |
Primary outcome
FaceQ Satisfaction surveys
Time frame: 6 months
Change from baseline in FACE-Q Satisfaction with questionnaire score for the treated regions
2 secondary outcomes
Global Aesthetic Improvement Scale (GAIS)
Time frame: 6 months
Investigator's Satisfaction Scale
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyntrFuge System in people with Facial Atrophy and Loss of Contour, run by Syntr Health Technologies, Inc. at 2 sites 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 23 inclusion and 0 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Zobi, EMBA (949-992-5728, info@syntrhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FaceQ Satisfaction surveys (time frame: 6 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 20 Aug 2026.