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

NCT ID: NCT05522426

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-12-31

Brief 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 microsized adipose tissue in the treatment sites.

Conditions

Facial Atrophy and Loss of Contour

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SyntrFuge System

Adipose tissue microsized via the SyntrFuge System

Group Type: EXPERIMENTAL

SyntrFuge System

Intervention Type: DEVICE

Microsized Adipose Tissue

Interventions

SyntrFuge System

Microsized Adipose Tissue

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syntr Health Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Newport Beach Site 1

Newport, California, United States

Newport Beach Site 2

Newport Beach, California, United States

Countries

United States

Other Identifiers

SHT-SYN-02

Identifier Type: -

Identifier Source: org_study_id