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Recruiting NCT06791564

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

Trial Parameters

Condition Liposuction
Sponsor Total Definer Research Group
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2024-01-15
Completion 2025-06-30
Interventions
AVELI

Brief 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 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 sca

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