Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting

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 Overview

• Status: Active, not recruiting
• Conditions: Facial Atrophy and Loss of Contour
• Intervention / Treatment: Device: SyntrFuge System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport, California, United States, 92660
      • Newport Beach Site 1
    • Newport Beach, California, United States, 92660
      • Newport Beach Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SyntrFuge System; Adipose tissue microsized via the SyntrFuge System	Device: SyntrFuge System; Microsized Adipose Tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FaceQ Satisfaction surveys	Change from baseline in FACE-Q Satisfaction with questionnaire score for the treated regions	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Aesthetic Improvement Scale (GAIS)	Change in facial regions characteristics as measured by the Global Aesthetic Improvement Scale (GAIS) form from baseline	6 months
Investigator's Satisfaction Scale	Change in facial regions characteristics as measured by the Investigator's Satisfaction Scale form from baseline	6 months

Collaborators and Investigators

• Sponsor: Syntr Health Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adipose Tissue; Microsized Fat Tissue; Facial Contouring; Fat Transfer
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: SHT-SYN-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes