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

NCT06791564 | Completed

• 1 other identifier: Aveli
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Aveli; Body contouring; Liposuction; Liposculpture; Cellulite reduction; Fibrosis Reduction; Fibrotic tissue

Outcome Measures

Primary Outcomes (3)

• Serious Adverse Events Incidence

  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

  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

• Photographic aesthetic outcomes analysis

  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

Study Arms (3)

Cellulite group (CG)

EXPERIMENTAL

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

Device: AVELI

Fibrosis Group (FG)

EXPERIMENTAL

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

Device: AVELI

Fibrosis and Cellulite Group (FCG)

EXPERIMENTAL

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

Device: AVELI

Interventions

AVELI DEVICE

Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.

Cellulite group (CG); Fibrosis Group (FG); Fibrosis and Cellulite Group (FCG)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Total Definer Research Group: lead

Study Sites (2)

Miami Aesthetic

Miami, Florida, 33131, United States

Location

Dhara Clinic

Bogotá, DC, Colombia

Location

Related Publications (7)

• Stevens WG, Green JB, Layt C, Kaminer MS, Harrington J, Fan L, Wall HC, Fabi S, Magnusson MR. Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months. Aesthet Surg J. 2023 Mar 15;43(4):455-466. doi: 10.1093/asj/sjac291.

  PMID: 36351188 BACKGROUND

• Stevens WG, Kaminer MS, Fabi SG, Fan L. Study of a New Controlled Focal Septa Release Cellulite Reduction Method. Aesthet Surg J. 2022 Aug 1;42(8):937-945. doi: 10.1093/asj/sjac010.

  PMID: 35089992 BACKGROUND

• Danilla S, Babaitis RA, Jara RP, Quispe DA, Andrades PR, Erazo CA, Albornoz CR, Sepulveda SL. High-Definition Liposculpture: What are the Complications and How to Manage Them? Aesthetic Plast Surg. 2020 Apr;44(2):411-418. doi: 10.1007/s00266-019-01475-6. Epub 2019 Aug 20.

  PMID: 31432229 BACKGROUND

• Bass LS, Kaminer MS. Insights Into the Pathophysiology of Cellulite: A Review. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S77-S85. doi: 10.1097/DSS.0000000000002388.

  PMID: 32976174 BACKGROUND

• Friedmann DP, Vick GL, Mishra V. Cellulite: a review with a focus on subcision. Clin Cosmet Investig Dermatol. 2017 Jan 7;10:17-23. doi: 10.2147/CCID.S95830. eCollection 2017.

  PMID: 28123311 BACKGROUND

• Gabriel A, Chan V, Caldarella M, Wayne T, O'Rorke E. Cellulite: Current Understanding and Treatment. Aesthet Surg J Open Forum. 2023 Jun 21;5:ojad050. doi: 10.1093/asjof/ojad050. eCollection 2023.

  PMID: 37424836 BACKGROUND

• Ferry AM, Chamata E, Dibbs RP, Rappaport NH. Avoidance and Correction of Deformities in Body Contouring. Semin Plast Surg. 2021 May;35(2):110-118. doi: 10.1055/s-0041-1727207. Epub 2021 Jun 8.

  PMID: 34121946 BACKGROUND

MeSH Terms

Conditions

Cellulite; Fibrosis

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking was feasible for this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Plastic Surgeon | Total Definer

Model Details: All the participants are categorized into the 3 different intervention groups based on the individual pre-procedure physical exam by the plastic surgeon. Once in the study group, the patient receives the intervention corresponding to this arm of the study.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: January 15, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After results publication (manuscript)
• Access Criteria: Request to the main author

Locations

CO (1); US (1)