Health TrialsbyHealthPanel

Within-Subject Comparison of Adipose Tissue Viability Following Liposuction

ConditionLiposuction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorApyx Medical

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AYON Ultrasound-Assisted Liposuction System

    Device

    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

    Device

    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

    Device

    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

    Device

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Assisted Liposuction ComparisonActive comparator 2 interventions
Group B: Aspiration Modality ComparisonActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Paired Difference in Adipocyte Viability Between AYON and VASER

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.

Time frame
Day 1
2

Paired Difference in Adipocyte Viability Between Vacuum and Peristaltic Pump Aspiration

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.

Time frame
Day 1

Secondary outcomes

1

Viable adipocyte density (cells/mL)

Determined by adipocyte counting combined with membrane integrity (live-dead) assessment using Trypan Blue exclusion

Time frame
Day 1
2

Fat composition analysis

Quantification of oil, fluid, and viable adipose fractions, as well as free oil fraction

Time frame
Day 1
3

SVF yield (cells/g fat)

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

Time frame
Day 1
4

Metabolic activity

Resazurin/Alamar Blue assay results

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Apyx Medical

Lead sponsor

Source ClinicalTrials.gov
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