Recruiting
Within-Subject Comparison of Adipose Tissue Viability Following Liposuction
Condition(s) studied
Liposuction
Investigational drug(s) / intervention(s)
AYON Ultrasound-Assisted Liposuction SystemVASER Ultrasound-Assisted Liposuction SystemAYON Power-Assisted Liposuction SystemVacuum Aspiration
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.
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.
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.
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (2)
| Facility | City | Region | Status |
|---|
| Mentor Plastic Surgery |
Concord |
Ohio |
Recruiting |
| Pearl Plastic Surgery |
Olympia |
Washington |
Recruiting |