Clinical trial NCT06791564: Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
Official title: Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liposuction
Cellulite
Cellulite Reduction
Fibrosis; Skin
Keywords: Aveli
Body contouring
Liposuction
Liposculpture
Cellulite reduction
Fibrosis Reduction
Fibrotic tissue
Lead sponsor: Total Definer Research Group
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serious Adverse Events Incidence
timeFrame: 30 days
measure: Patient Satisfaction Scores
timeFrame: 6 months
measure: Photographic aesthetic outcomes analysis
timeFrame: One month, three months, six months, and nine months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Aesthetic
state: Florida
city: Bogota
country: Colombia
facility: Dhara Clinic
state: DC
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.