Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery

Launched by TOTAL DEFINER RESEARCH GROUP · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called AVELI, which is designed to reduce the appearance of cellulite and fibrous tissue in patients undergoing High-Definition Liposculpture, a type of body contouring surgery. The main goal is to see if AVELI can safely help improve both the look and feel of the skin after the surgery, without causing any serious side effects. The researchers will look at how satisfied patients are with the results and use 3D imaging to objectively measure any changes in their appearance over time.

To participate in this study, you need to be an adult between 18 and 60 years old who is having High-Definition Liposculpture and has noticeable cellulite or fibrosis. You must not be pregnant, have certain skin conditions, or be significantly overweight. During the study, participants will undergo the standard liposuction procedure, and AVELI will be applied to the affected areas. Researchers will collect data before the surgery and at follow-up visits to assess safety and effectiveness. This trial offers a chance to explore a promising new treatment option for those looking to improve their body contouring results.

Gender

ALL

Eligibility 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.