Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery (AVE001)

April 22, 2026 updated by: Alfredo Hoyos, Total Definer Research Group

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • DC
      • Bogotá, DC, Colombia
        • Dhara Clinic
  • United States
    • Florida
      • Miami, Florida, United States, 33131
        • Miami Aesthetic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.
  • Patients with any chronic disease non-compliant with treatment or non-adequately controlled.
  • Positive pregnancy test or planning on getting pregnant in the next 6 months.
  • Patients with fever or any other symptoms/signs of infection.
  • Active smokers or chronic smokers with recent quit (≤ 4-8 weeks).
  • Patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 times baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cellulite group (CG)
Patients with any degree of clinically evident cellulite undergoing HDL + AVÉLI treatment for Cellulite.
Device: AVELI
Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.
Experimental: Fibrosis Group (FG)
Patients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue.
Device: AVELI
Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.
Experimental: Fibrosis and Cellulite Group (FCG)
Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both.
Device: AVELI
Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photographic aesthetic outcomes analysis
Time Frame: One month, three months, six months, and nine months
Through 3D camera photos and photographic software, an analysis will objectively calculate the differences between preoperative contour defects (fibrosis and/or cellulite) and postoperative improvement.
One month, three months, six months, and nine months
Serious Adverse Events Incidence
Time Frame: 30 days
Incidence of intervention-related serious adverse events (SAE). SAE were defined as any adverse events that met one or more of the following criteria: required hospital care, required additional medical intervention or treatment, produced any disability, were classified as life-threatening, or resulted in the death of the patient.
30 days
Patient Satisfaction Scores
Time Frame: 6 months

Patient-reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS) for the reduction of cellulite and/or fibrosis.

The GAIS is a standardized scale used primarily in cosmetic and dermatological treatments to assess the overall aesthetic improvement of a patient after a procedure. It consist of three questions:

  • how do you feel about your appearance after surgery? Possible answers: Very much improved, much improved, slightly improved, no change.
  • Are you satisfied with the surgery? Very satisfied, satisfied, not satisfied.
  • Would you recommend the surgical procedure? Possible answers: Yes, perhaps, no.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Total Definer Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aveli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Depending upon reasonable request

IPD Sharing Time Frame

After results publication (manuscript)

IPD Sharing Access Criteria

Request to the main author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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