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RECRUITING
NCT06791564
NA

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

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-01-15

Completion Date

2025-12-15

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

DEVICE

AVELI

Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.

Locations (2)

Miami Aesthetic

Miami, Florida, United States

Dhara Clinic

Bogotá, DC, Colombia