CompletedNot Applicable

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

United States, Colombia130 participantsStarted 2024-01-15

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. *…

What they're measuring

Serious Adverse Events Incidence

Timeframe: 30 days

Patient Satisfaction Scores

Timeframe: 6 months

Photographic aesthetic outcomes analysis

Timeframe: One month, three months, six months, and nine months

Trial details

NCT IDNCT06791564

SponsorTotal Definer Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30