SyntrFuge™ Processed Fat Grafting for Facial Atrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to determine if the SyntrFuge System (Autologous Microsized Adipose Tissue Therapy) can enhance facial appearance using a person’s own fat. Participants will receive injections of their own fat, processed in a novel way, to aid in facial contouring. The trial seeks individuals who have experienced noticeable facial thinning or volume loss and have not recently undergone cosmetic treatments like fillers or lasers. Those with conditions such as facial atrophy who have not had recent cosmetic procedures may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative treatments for facial volume loss.
Will I have to stop taking my current medications?
The trial requires you to stop taking anti-coagulation, anti-platelet, or thrombolytic medications, as well as anti-inflammatory drugs like aspirin or ibuprofen, from 10 days before to 3 days after the injection. There is a 10-day washout period for these medications.
What prior data suggests that the SyntrFuge System is safe for facial atrophy treatment?
Research shows that systems like SyntrFuge for fat grafting are generally well-tolerated. Previous studies on using a patient's own fat for facial procedures have demonstrated this method's safety. Evidence indicates that the SyntrFuge System maintains the health of fat cells, which is crucial for effective and safe treatment.
Reports of negative reactions are rare, and available data suggests they are minimal. Since this method is already used in other facial procedures, it provides some confidence in its safety. However, because this study is in an early phase, monitoring for potential risks or side effects during the trial remains important.12345Why are researchers excited about this trial?
Unlike traditional treatments for facial atrophy that often involve synthetic fillers or surgical interventions, the SyntrFuge System uses a unique approach by processing a patient’s own adipose (fat) tissue. This method microsizes the tissue, potentially offering a more natural and biocompatible option for facial restoration. Researchers are excited because this technique might reduce the risk of rejection and provide a longer-lasting, more natural appearance compared to existing options.
What evidence suggests that the SyntrFuge System is effective for facial atrophy?
Research shows that the SyntrFuge System has produced positive results for treating facial atrophy, which involves a loss of volume in the face. One study found it effectively restored volume in the cheeks and the lines from the nose to the mouth (nasolabial folds). In this trial, participants will receive treatment with the SyntrFuge System. Previous studies indicate that 82% of patients reported being very satisfied or somewhat satisfied with their results. The SyntrFuge System is also FDA cleared, meaning it has undergone review for safety and effectiveness. These findings suggest that the system could be a promising option for improving facial shape and appearance.26789
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SyntrFuge System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syntr Health Technologies, Inc.
Lead Sponsor