RecruitingNot ApplicableNCT06791564

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

Sponsor

Total Definer Research Group

Enrollment

150 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Liposuction

Summary

This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture, exploring if AVELI improves the aesthetic outcomes, and reduced the clinically evident cellulite and/or fibrosis. The main questions this study seeks to answer are: * Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events? * How effective is AVELI in improving patient-reported outcomes and aesthetic appearance? Through this study, the study team aims to evaluate the safety and effectiveness of AVELI. The study procedures include: * Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, and satisfaction scores. * All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and/or fibrosis release. * Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria7

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 Criteria14

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.