Liposuction
Conditions
Keywords
Adipose tissue, Adipose tissue viability, Fat harvest, Liposuction, Ultrasound-assisted liposuction, Power-assisted liposuction, Aspiration modality, VASER, AYON, Stromal vascular fraction, Metabolic activity, Fat composition, Within-subject comparison, Paired samples
Brief summary
This study will evaluate and compare the quality of adipose (fat) tissue harvested using different liposuction technologies and aspiration methods. Each participant will serve as their own control, with paired fat samples collected from anatomically matched treatment areas. The study will evaluate adipocyte viability and other characteristics of the harvested tissue, including viable adipocyte density, stromal vascular fraction, metabolic activity, and fat composition. The goal of the study is to better understand how different liposuction technologies and aspiration methods affect the quality and characteristics of harvested adipose tissue.
Detailed description
This study will compare the quality of fat tissue collected using different liposuction technologies and aspiration methods. Participants will have paired samples of fat tissue collected from similar areas of the body during their planned liposuction procedure. Each participant will serve as their own comparison. The study will evaluate the viability and characteristics of the collected fat tissue, including the number of viable fat cells, the types and number of cells present in the tissue, metabolic activity, and the composition of the collected tissue. The study will compare these characteristics between the different liposuction technologies and aspiration methods. The goal of this study is to better understand how different liposuction technologies and aspiration methods affect the quality and characteristics of harvested fat tissue. Participants are not expected to receive any direct clinical benefit from participating in the study beyond that associated with their planned liposuction procedure.
Interventions
DEVICEAYON Ultrasound-Assisted Liposuction System
Ultrasound-assisted liposuction using the AYON UAL system. In this arm, AYON UAL is compared with VASER ultrasound-assisted liposuction using paired adipose tissue samples collected from anatomically matched treatment areas. Study-specific UAL settings and treatment parameters are defined by the protocol.
DEVICEVASER Ultrasound-Assisted Liposuction System
Ultrasound-assisted liposuction using the VASER system. In this arm, VASER is compared with AYON ultrasound-assisted liposuction using paired adipose tissue samples collected from anatomically matched treatment areas. Study-specific UAL settings and treatment parameters are defined by the protocol.
DEVICEAYON Power-Assisted Liposuction System
Power-assisted liposuction using the AYON PL system with a peristaltic pump. In this arm, the peristaltic pump aspiration modality is compared with vacuum aspiration using paired adipose tissue samples collected from anatomically matched treatment areas.
DEVICEVacuum Aspiration
Vacuum aspiration used for adipose tissue harvest in the power-assisted liposuction comparison. In this arm, vacuum aspiration is compared with AYON power-assisted liposuction using a peristaltic pump through paired adipose tissue samples collected from anatomically matched treatment areas.
Sponsors
Apyx Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
There is no indication in the protocol that participants, investigators/care providers, or outcome assessors are masked. The device/treatment being used is known during the procedure.
Intervention model description
Participants are assigned to one of two comparison arms. Within each arm, paired adipose tissue samples are collected from anatomically matched treatment areas, with each participant serving as their own control.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 30 to 65 years, inclusive. * Planned elective liposuction/body contouring procedure involving two or more anatomical areas (e.g., arms, abdomen, flanks, thighs, and/or back) with sufficient distribution to permit collection of paired adipose tissue samples from contralateral or anatomically matched treatment areas. * Investigator determines the subject is an appropriate candidate for the planned procedure and study participation. * Adequate adipose tissue is present to permit collection of required paired fat samples without impacting the planned surgical outcome. * Able to understand and sign the informed consent form. * Willing and able to comply with study requirements. * If applicable, female subjects of childbearing potential must have a negative urine pregnancy test on the day of procedure.
Exclusion criteria
* Prior liposuction or surgical intervention in the planned treatment areas that, in the opinion of the investigator, may affect adipose tissue characteristics or study assessments. * Prior treatment of the planned treatment areas with energy-based devices (e.g., ultrasound, radiofrequency, laser) that, in the opinion of the investigator, may affect adipose tissue characteristics or study assessments. * Significant skin laxity, fibrosis, scarring, or other abnormal tissue characteristics in the planned treatment areas that could impact fat harvest quality or comparability between sites. * Current smoker or use of nicotine-containing products within 4 weeks prior to the procedure. * Known metabolic or systemic conditions that may affect adipose tissue biology or wound healing, including but not limited to: * uncontrolled diabetes mellitus * significant vascular disease * connective tissue disorders * Use of medications known to significantly affect fat metabolism, tissue healing, or inflammatory response, including: * chronic systemic corticosteroids * immunosuppressive therapies * GLP-1 receptor agonists (e.g., semaglutide, tirzepatide) within 4 weeks prior to the procedure * Active local or systemic infection at the time of the procedure. * Known coagulopathy or use of anticoagulant therapy that cannot be safely discontinued prior to surgery. * Pregnant or breastfeeding subjects. * Body mass index (BMI) outside the range of 20-35 kg/m², inclusive. * Inadequate adipose tissue volume or distribution to permit paired sample collection from contralateral or anatomically matched areas. * Participation in another interventional clinical study that, in the opinion of the investigator, could interfere with study endpoints. * Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation or could confound study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paired Difference in Adipocyte Viability Between AYON and VASER | Day 1 | Adipocyte viability (%) will be assessed using membrane integrity (live/dead) analysis by Trypan Blue exclusion. The primary analysis will evaluate the paired difference in adipocyte viability between AYON ultrasound-assisted liposuction and VASER across paired adipose tissue samples. |
| Paired Difference in Adipocyte Viability Between Vacuum and Peristaltic Pump Aspiration | Day 1 | Adipocyte viability (%) will be assessed using membrane integrity (live/dead) analysis by Trypan Blue exclusion. The primary analysis will evaluate the paired difference in adipocyte viability between vacuum and peristaltic pump aspiration across paired adipose tissue samples in the power-assisted liposuction arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viable adipocyte density (cells/mL) | Day 1 | Determined by adipocyte counting combined with membrane integrity (live-dead) assessment using Trypan Blue exclusion |
| Fat composition analysis | Day 1 | Quantification of oil, fluid, and viable adipose fractions, as well as free oil fraction |
| SVF yield (cells/g fat) | Day 1 | Determined by enzymatic digestion (e.g., collagenase) of a measured mass of processed adipose tissue, recovery of the stromal vascular fraction pellet by centrifugation, and viable total nucleated cell (TNC) counting |
| Metabolic activity | Day 1 | Resazurin/Alamar Blue assay results |
| Aspiration rate (mL/min) (Arm 2 only) | Day 1 | Calculated as total aspirate volume divided by active aspiration time |
| Intraoperative adverse events | Day 1 | Adverse events occurring during collection of paired adipose tissue samples |
Countries
United States
Contacts
CONTACTGlobal Senior Director, Clinical Affairs
PRINCIPAL_INVESTIGATORPaul Vanek, MD
Mentor Plastic Surgery
Outcome results
None listed