Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrF… (NCT05522426) | Clinical Trial Compass
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Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting
United States50 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
âś“. Subjects aged of 18-70 years old
âś“. Willing and able to read and sign the informed consent and other study materials
âś“. Written informed consent has been obtained prior to any study-related procedures
âś“. Subjects are ambulatory
âś“. Ability to follow study instructions and complete study assessment tools including the subject diary
âś“. Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
âś“. 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
âś•. Subjects without decisional capacity
âś•. Subjects unable to give informed, written consent
âś•. Subjects with active infection (redness, swelling, pain, suppuration)
âś•. Subjects with any uncontrolled systemic disease
âś•. Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
âś•. Subjects with conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma