Using AVELI to reduce cellulite and fibrosis during body contouring surgery
Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
This study is testing if a treatment called AVELI can help reduce cellulite and tough tissue in people getting body contouring surgery to see if it makes their results look better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Total Definer Research Group Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06791564 on ClinicalTrials.gov |
What this trial studies
This prospective study evaluates the safety and effectiveness of AVELI in reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture. The study aims to determine if AVELI improves aesthetic outcomes and reduces clinically evident cellulite and fibrosis. Participants will undergo a standardized liposculpture technique with AVELI applied to identified areas, and data will be collected on surgical variables, adverse events, and patient satisfaction. The study will adhere to ethical guidelines, including informed consent and data confidentiality.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 60 with clinically evident cellulite or fibrosis undergoing High-Definition Liposculpture.
Not a fit: Patients requiring fat grafting for contour irregularities or those with a history of abnormal scarring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the aesthetic results of body contouring surgeries by effectively reducing cellulite and fibrosis.
How similar studies have performed: While similar approaches have been explored, this specific use of AVELI in conjunction with High-Definition Liposculpture is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing HDL between 18 and 60 years old. * Non-gender specific. * American Association of Anesthesiologist Risk Assessment (ASA) ≤ 2. * Body Mass Index (BMI) ≥20 and ≤ 32 kg/m2. * Patients with any degree of clinically evident cellulite in any body area. * Patients with prior liposuction procedures with any degree of fibrosis in any body area. * Patients undergoing additional procedures such as, but not limited to: Rhinoplasty, Mammaplasty, Mastopexy, mini tummy tuck, full tummy tuck, brachioplasty, thighplasty, fat grafting. The procedure could not be related to the treatment of fibrosis or cellulite. Exclusion Criteria: * Patients requiring SQ fat grafting for the amendment of any contour irregularity. * Patients requiring other devices/drugs for skin contraction and/or cellulite treatment for the next 6 months (RF, US, Enzymes, etc.). * Patients undergoing Face Lift procedures. * Patients with any history of abnormal scarring and/or hypertrophic scars and or keloids. * Patients with Caprini score ≥ 8. * Patients with past medical history of connective tissue disease with active disease and/or recent relapse. * Patients with past medical history thromboembolic disease or any other condition with an increased risk of coagulopathy (i.e., SLE, RA, APS). * Patients using aspirin or any anticoagulant within 14 days and 5 days prior to surgery, respectively. * Patients with a PMH of epilepsy or any epileptic syndrome and or vascular disease. * Patients with any chronic disease non-compliant with treatment or non-adequately controlled. * Positive pregnancy test or planning on getting pregnant in the next 6 months. * Patients with fever or any other symptoms/signs of infection. * Active smokers or chronic smokers with recent quit (≤ 4-8 weeks). * Patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) \>1.5 times baseline.
Where this trial is running
Miami, Florida and 1 other locations
- Miami Aesthetic — Miami, Florida, United States (Recruiting)
- Dhara Clinic — Bogota, Dc, Colombia (Recruiting)
Study contacts
- Study coordinator: Alfredo Hoyos, MD
- Email: alhoyos@gmail.com
- Phone: +13059154274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.