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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06791564 on ClinicalTrials.gov