A Prospective Within-Subject Comparison of Adipose Tissue Viability and Cellular Characteristics Following Ultrasound- and Power-Assisted Liposuction and Aspiration Modalities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Apyx Medical
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Paired Difference in Adipocyte Viability Between AYON and VASER
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ultrasound-Assisted Liposuction Comparison
AYON ultrasound-assisted liposuction (UAL) is compared with VASER ultrasound-assisted liposuction using paired adipose tissue samples collected from anatomically matched treatment areas. The primary outcome is the paired difference in adipocyte viability, with additional evaluation of adipose tissue characteristics.
干预措施: AYON Ultrasound-Assisted Liposuction System (Device)
Ultrasound-Assisted Liposuction Comparison
AYON ultrasound-assisted liposuction (UAL) is compared with VASER ultrasound-assisted liposuction using paired adipose tissue samples collected from anatomically matched treatment areas. The primary outcome is the paired difference in adipocyte viability, with additional evaluation of adipose tissue characteristics.
干预措施: VASER Ultrasound-Assisted Liposuction System (Device)
Aspiration Modality Comparison
AYON power-assisted liposuction (PL) using a peristaltic pump is compared with vacuum aspiration using paired adipose tissue samples collected from anatomically matched treatment areas. The primary outcome is the paired difference in adipocyte viability, with additional exploratory evaluation of adipose tissue characteristics.
干预措施: AYON Power-Assisted Liposuction System (Device)
Aspiration Modality Comparison
AYON power-assisted liposuction (PL) using a peristaltic pump is compared with vacuum aspiration using paired adipose tissue samples collected from anatomically matched treatment areas. The primary outcome is the paired difference in adipocyte viability, with additional exploratory evaluation of adipose tissue characteristics.
干预措施: Vacuum Aspiration (Device)
结局指标
主要结局
Paired Difference in Adipocyte Viability Between AYON and VASER
时间窗: 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
时间窗: 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.
次要结局
- Aspiration rate (mL/min) (Arm 2 only)(Day 1)
- Intraoperative adverse events(Day 1)
- Viable adipocyte density (cells/mL)(Day 1)
- Fat composition analysis(Day 1)
- SVF yield (cells/g fat)(Day 1)
- Metabolic activity(Day 1)