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Adipose Tissue Processing Device
SyntrFuge™ Processed Fat Grafting for Facial Atrophy
N/A
Waitlist Available
Research Sponsored by Syntr Health Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether fat processed with the SyntrFuge system can be used for facial aesthetics and contouring. If successful, the fat will be injected into the treatment sites.
Who is the study for?
This trial is for adults aged 18-70 seeking facial fat grafting without severe allergies, uncontrolled diseases, or recent cosmetic procedures in the area. Participants must not be pregnant or planning pregnancy and should avoid other facial treatments during the study.Check my eligibility
What is being tested?
The SyntrFuge™ System is being tested for its effectiveness in processing adipose tissue for improving facial aesthetics. Patients will receive injections of their own processed fat into targeted areas of their face.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as redness, swelling, pain, bruising, infection risk and possibly allergic responses to the injected material.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FaceQ Satisfaction surveys
Secondary outcome measures
Global Aesthetic Improvement Scale (GAIS)
Investigator's Satisfaction Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: SyntrFuge SystemExperimental Treatment1 Intervention
Adipose tissue microsized via the SyntrFuge System
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Who is running the clinical trial?
Syntr Health Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
236 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.I am unable to understand and sign the consent form.I am unable to make my own medical decisions.I have skin conditions like acne or scarring in the area to be treated.I've had hyaluronic acid facial fillers in the last year.I do not have any uncontrolled illnesses.I am not willing to have fat graft injections.I am not pregnant or breastfeeding.I currently have an active infection with symptoms like redness, swelling, or pain.I can walk on my own without help.I haven't had immunosuppressive therapy or steroids in the last 3 months.I agree not to have any cosmetic treatments in the study area during the trial.I haven't had cosmetic skin treatments like Botox or laser in the last 5 months.I haven't had facial surgery or treatments that could affect the study.I haven't taken blood thinners or anti-inflammatory drugs close to my injection date.
Research Study Groups:
This trial has the following groups:- Group 1: SyntrFuge System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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