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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSyntr Health Technologies, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • SyntrFuge System

    Device

    Microsized Adipose Tissue

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: SyntrFuge SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

FaceQ Satisfaction surveys

Change from baseline in FACE-Q Satisfaction with questionnaire score for the treated regions

Time frame
6 months

Secondary outcomes

1

Global Aesthetic Improvement Scale (GAIS)

Change in facial regions characteristics as measured by the Global Aesthetic Improvement Scale (GAIS) form from baseline

Time frame
6 months
2

Investigator's Satisfaction Scale

Change in facial regions characteristics as measured by the Investigator's Satisfaction Scale form from baseline

Time frame
6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: