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

Total Definer Research Group

Status: Enrolling

Conditions: Fibrosis; Skin; Liposuction; Cellulite; Cellulite Reduction

Treatments: Device: AVELI

Study type: Interventional

Funder types: Other

Identifiers

NCT06791564

Aveli

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Cellulite group (CG)

Experimental group

Description:

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

Treatment:

Device: AVELI

Fibrosis Group (FG)

Experimental group

Description:

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

Treatment:

Device: AVELI

Fibrosis and Cellulite Group (FCG)

Experimental group

Description:

Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both.

Treatment:

Device: AVELI