Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
NCT06791564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-04-28
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).
Conditions
- Liposuction
- Cellulite
- Cellulite Reduction
- Fibrosis; Skin
Interventions
- DEVICE
-
AVELI
Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.
Sponsors & Collaborators
-
Total Definer Research Group
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-15
- Primary Completion
- 2025-12-30
- Completion
- 2026-03-01
Countries
- United States
- Colombia
Study Locations
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