NCT07820397 · Apyx Medical
Within-Subject Comparison of Adipose Tissue Viability Following Liposuction
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
AYON 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.
DEVICE
VASER 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.
DEVICE
AYON 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.
DEVICE
Vacuum 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.
Primary outcome measures
Paired Difference in Adipocyte Viability Between AYON and VASER
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Concord, Ohio
- Olympia, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2026 · Source of record for eligibility and locations