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

Last updated: January 19, 2025
Sponsor: Total Definer Research Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liposuction

Scar Tissue

Treatment

AVELI

Clinical Study ID

NCT06791564
Aveli
  • Ages 18-60
  • All Genders

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. AVELI is a minimally invasive procedure used for the treatment of cellulite.

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?

In this study, the research team will explore the use of AVELI for cellulite, fibrosis, and cellulite plus fibrosis, in 3 independent study arms. Through this study the safety and effectiveness aims to be evaluated. The participants will be adult patients (between 18-60 years) undergoing High-Definition Liposculpture, with clinical evidence of cellulite and/or fibrosis. The participants can not be pregnant, have history of scaring/healing problems, severe dermatological conditions, be obese, or have important comorbidities.

The study procedures include:

  • Baseline data collection.

  • All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and for fibrosis release.

  • Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).

Primary outcome:

  • Safety assessed by the absence of serious adverse events within 30 days.

  • Effectiveness evaluated using the Global Aesthetic Improvement Scale (GAIS) for patient satisfaction and 3D imaging analysis for objective evaluation.

Secondary outcomes:

  • Explore the aesthetic outcomes satisfaction with the High-Definition Liposculpture measured by participant-reported satisfaction (GAIS) and objective contour improvements (3D analysis).

Eligibility Criteria

Inclusion

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 bodyarea.

  • 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 offibrosis or cellulite.

Exclusion

Exclusion Criteria:

  • Patients requiring SQ fat grafting for the amendment of any contour irregularity.

  • Patients requiring other devices/drugs for skin contraction and/or cellulitetreatment 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 orkeloids.

  • Patients with Caprini score ≥ 8.

  • Patients with past medical history of connective tissue disease with active diseaseand/or recent relapse.

  • Patients with past medical history thromboembolic disease or any other conditionwith an increased risk of coagulopathy (i.e., SLE, RA, APS).

  • Patients using aspirin or any anticoagulant within 14 days and 5 days prior tosurgery, 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-adequatelycontrolled.

  • 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 Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: AVELI
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
December 15, 2025

Study Description

Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking.

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: Patients with any degree of clinically evident cellulite undergoing HDL + AVELI treatment for Cellulite.

  • Fibrosis Group: Patients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue.

  • Fibrosis and Cellulite Group: Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVELI treatment for both

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.

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.

Connect with a study center

  • Dhara Clinic

    Bogota, DC
    Colombia

    Active - Recruiting

  • Miami Aesthetic

    Miami, Florida 33131
    United States

    Active - Recruiting

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