NCT06791564

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Total Definer Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking. Ethical Considerations: * IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB). * Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained. * Data Confidentiality: All participant data will be anonymized and securely stored. Eligible patients will be approached, the study aims, objectives, procedures, and voluntary participation will be explained. In case patient consent to participate, a written informed consent will be signed. The patients will be comprehensively evaluated by the plastic surgeon, and assigned to a group based on their individual physical evaluation findings: Cellulite Group, Fibrosis Group, Fibrosis and Cellulite Group. Study Locations: * Dhara Clinic (Bogota, Colombia) * Miami Aesthetic Center (Miami, FL - USA) Data Collection: * Demographic, Clinical, and surgical variables are going to be collected in an Excel-based password protected database. * Other procedure related variables are also going to be collected in the same database, including pain assessment in the immediate postoperative, hemoglobin and hematocrit levels, time to discharge, and complications \& management. * 3D photographic analysis will be employed to analyze preoperative, and postoperative images at 1, 3, 6 and 9 months post procedure. Then the changes will be objectively compared using Quantificare Photographical Software, through the different timepoints to evaluate the objective contour defects and postoperative improvement changes. * Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively.

Conditions

• Liposuction
• Cellulite
• Cellulite Reduction
• Fibrosis; Skin

Interventions

Type	Name	Description
DEVICE	AVELI	Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-06-30
• Completion: 2025-12-15
• First posted: 2025-01-24
• Last updated: 2025-04-30

Locations

2 sites across 2 countries: United States, Colombia