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LiposuctionNCT07820397

Within-Subject Comparison of Adipose Tissue Viability Following Liposuction

A study testing AYON Ultrasound-Assisted Liposuction System, VASER Ultrasound-Assisted Liposuction System and AYON Power-Assisted Liposuction System in people with Liposuction, run by Apyx Medical at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Liposuction
What is being tested?
AYON Ultrasound-Assisted Liposuction System, VASER Ultrasound-Assisted Liposuction System and AYON Power-Assisted Liposuction System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
6 Aug 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Global Senior Director, Clinical Affairs contact

1-800-537-2790

research@apyxmedical.com

United States2 sites, 2 recruiting

  • Mentor Plastic Surgery

    Concord, Ohio, 44077

    Petula Kelly, 440-205-5750, petula@paulvanekmd.com

    Mindy Renick, 440-205-5750, Mindy@paulvanekmd.com

    Recruiting

  • Pearl Plastic Surgery

    Olympia, Washington, 98506

    Shauna Smith-Ewers, 360-878-9300, shauna@pearlplasticsurgery.com

    Elle Mortensen, 360-878-9300, elle@pearlplasticsurgery.com

    Recruiting

Other trials in United States

About this study

Official title: A Prospective Within-Subject Comparison of Adipose Tissue Viability and Cellular Characteristics Following Ultrasound- and Power-Assisted Liposuction and Aspiration Modalities

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.

Read the 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.

Conditions
Liposuction
Being tested
AYON Ultrasound-Assisted Liposuction System, VASER Ultrasound-Assisted Liposuction System, AYON Power-Assisted Liposuction System, Vacuum Aspiration
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AYON Ultrasound-Assisted Liposuction SystemDevice

    Also called AYON UAL System, AYON

    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 SystemDevice

    Also called VASER

    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 SystemDevice

    Also called AYON PL, AYON PL 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 AspirationDevice

    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 groups in NCT07820397
Study groupRoleWhat they receive
Ultrasound-Assisted Liposuction ComparisonActive comparatorAYON 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.
Receives: Device: AYON Ultrasound-Assisted Liposuction System; Device: VASER Ultrasound-Assisted Liposuction System
Aspiration Modality ComparisonActive comparatorAYON 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.
Receives: Device: AYON Power-Assisted Liposuction System; Device: Vacuum Aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Day 1

Secondary outcomes (6)

  1. Viable adipocyte density (cells/mL)

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

    Measured: Day 1

  2. Fat composition analysis

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

    Measured: 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

    Measured: Day 1

  4. Metabolic activity

    Resazurin/Alamar Blue assay results

    Measured: Day 1

  5. Aspiration rate (mL/min) (Arm 2 only)

    Calculated as total aspirate volume divided by active aspiration time

    Measured: Day 1

  6. Intraoperative adverse events

    Adverse events occurring during collection of paired adipose tissue samples

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2026
  2. Study start6 Aug 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07820397
Sponsor's protocol ID
APX-AY-26-02
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared with other researchers. Study results will be reported in aggregate.

Publications

  • Pu LL. Mechanisms of Fat Graft Survival. Ann Plast Surg. 2016 Feb;77 Suppl 1:S84-6. doi: 10.1097/SAP.0000000000000730.

    PubMed 26808753

  • Fontes T, Brandao I, Negrao R, Martins MJ, Monteiro R. Autologous fat grafting: Harvesting techniques. Ann Med Surg (Lond). 2018 Nov 13;36:212-218. doi: 10.1016/j.amsu.2018.11.005. eCollection 2018 Dec.

    PubMed 30505441

  • Mojallal A, Auxenfans C, Lequeux C, Braye F, Damour O. Influence of negative pressure when harvesting adipose tissue on cell yield of the stromal-vascular fraction. Biomed Mater Eng. 2008;18(4-5):193-7.

    PubMed 19065021

  • Yoshimura K, Suga H, Eto H. Adipose-derived stem/progenitor cells: roles in adipose tissue remodeling and potential use for soft tissue augmentation. Regen Med. 2009 Mar;4(2):265-73. doi: 10.2217/17460751.4.2.265.

    PubMed 19317645

  • Molitor M, Travnickova M, Mestak O, Christodoulou P, Sedlar A, Bacakova L, Lucchina S. The Influence of High and Low Negative Pressure Liposuction and Various Harvesting Techniques on the Viability and Function of Harvested Cells-a Systematic Review of Animal and Human Studies. Aesthetic Plast Surg. 2021 Oct;45(5):2379-2394. doi: 10.1007/s00266-021-02249-9. Epub 2021 Apr 19.

    PubMed 33876289

  • Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.

    PubMed 16936550

  • Fisher C, Grahovac TL, Schafer ME, Shippert RD, Marra KG, Rubin JP. Comparison of harvest and processing techniques for fat grafting and adipose stem cell isolation. Plast Reconstr Surg. 2013 Aug;132(2):351-361. doi: 10.1097/PRS.0b013e3182958796.

    PubMed 23584621

  • Shiffman MA, Mirrafati S. Fat transfer techniques: the effect of harvest and transfer methods on adipocyte viability and review of the literature. Dermatol Surg. 2001 Sep;27(9):819-26. doi: 10.1046/j.1524-4725.2001.01062.x.

    PubMed 11553171

  • Eto H, Suga H, Matsumoto D, Inoue K, Aoi N, Kato H, Araki J, Yoshimura K. Characterization of structure and cellular components of aspirated and excised adipose tissue. Plast Reconstr Surg. 2009 Oct;124(4):1087-1097. doi: 10.1097/PRS.0b013e3181b5a3f1.

    PubMed 19935292

  • Kurita M, Matsumoto D, Shigeura T, Sato K, Gonda K, Harii K, Yoshimura K. Influences of centrifugation on cells and tissues in liposuction aspirates: optimized centrifugation for lipotransfer and cell isolation. Plast Reconstr Surg. 2008 Mar;121(3):1033-1041. doi: 10.1097/01.prs.0000299384.53131.87.

    PubMed 18317153

  • Rohrich RJ, Sorokin ES, Brown SA. In search of improved fat transfer viability: a quantitative analysis of the role of centrifugation and harvest site. Plast Reconstr Surg. 2004 Jan;113(1):391-5; discussion 396-7. doi: 10.1097/01.PRS.0000097293.56504.00.

    PubMed 14707664

  • Shauly O, Gould DJ, Ghavami A. Fat Grafting: Basic Science, Techniques, and Patient Management. Plast Reconstr Surg Glob Open. 2022 Mar 18;10(3):e3987. doi: 10.1097/GOX.0000000000003987. eCollection 2022 Mar.

    PubMed 35317456

  • Ruff PG 4th, Garcia O Jr, Nykiel MJ, Galanis CJ. Consensus-based Recommendations for Vibration Amplification of Sound Energy at Resonance Ultrasound-assisted Liposuction. Plast Reconstr Surg Glob Open. 2023 Jul 11;11(7):e5110. doi: 10.1097/GOX.0000000000005110. eCollection 2023 Jul.

    PubMed 37441115

  • Cimino WW. Ultrasonic surgery: power quantification and efficiency optimization. Aesthet Surg J. 2001 May;21(3):233-41. doi: 10.1067/maj.2001.116006.

    PubMed 19331898

  • Kloehn RA. Liposuction With "Sonic Sculpture": Six Years' Experience With More Than 600 Patients. Aesthetic Surgery Journal. 1996/01/01/ 1996;16(2):123-128

Questions about this trial

What is this clinical trial studying?

A study testing AYON Ultrasound-Assisted Liposuction System, VASER Ultrasound-Assisted Liposuction System and AYON Power-Assisted Liposuction System in people with Liposuction, run by Apyx Medical at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Global Senior Director, Clinical Affairs (1-800-537-2790, research@apyxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paired Difference in Adipocyte Viability Between AYON and VASER (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07820397, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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