ClinicalTrials.gg
RecruitingNCT07820397Updated Sep 15, 2026

Within-Subject Comparison of Adipose Tissue Viability Following Liposuction

An interventional study of AYON Ultrasound-Assisted Liposuction System and VASER Ultrasound-Assisted Liposuction System in Liposuction, sponsored by Apyx Medical. Recruiting at 2 sites in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Apyx Medical · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

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.

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.

02

Conditions studied

  • Liposuction

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
03

In context

Lead sponsor

Apyx Medical is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.
  • Willing and able to comply with study requirements.
  • If applicable, female subjects of must have a negative urine pregnancy test on the day of procedure.

Exclusion criteria

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
    • 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.
  • (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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    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.

    Device: AYON Ultrasound-Assisted Liposuction System · Device: VASER Ultrasound-Assisted Liposuction System

  • Active comparator
    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.

    Device: AYON Power-Assisted Liposuction System · Device: Vacuum Aspiration

Interventions

  • DeviceAYON 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.

    Also known as: AYON UAL System, AYON

  • DeviceVASER 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.

    Also known as: VASER

  • DeviceAYON 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.

    Also known as: AYON PL, AYON PL System

  • DeviceVacuum 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.

06

What researchers measure

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

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

    Calculated as total aspirate volume divided by active aspiration time

    Time frame: Day 1

  6. Intraoperative adverse events

    Adverse events occurring during collection of paired adipose tissue samples

    Time frame: Day 1

07

Study locations

2 of 2 sites recruiting
  • Mentor Plastic Surgery
    Concord, Ohio 44077, United States
    Recruiting
  • Pearl Plastic Surgery
    Olympia, Washington 98506, United States
    Recruiting
08

References and documents

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
  • Beckenstein MS, Grotting JC. Ultrasound-assisted lipectomy using the solid probe: a retrospective review of 100 consecutive cases. Plast Reconstr Surg. 2000 May;105(6):2161-74; discussion 2175-9. doi: 10.1097/00006534-200005000-00041. PubMed 10839419 ↗
  • Lawrence N, Coleman WP 3rd. The biologic basis of ultrasonic liposuction. Dermatol Surg. 1997 Dec;23(12):1197-200. doi: 10.1111/j.1524-4725.1997.tb00474.x. PubMed 9426668 ↗
  • Garcia O. Ultrasound-Assisted Liposuction Current Concepts and Techniques: Current Concepts and Techniques. 2020.
  • Jewell ML. Ultrasonic-Assisted Liposuction: Introduction and Historic Perspectives. In: Garcia Jr O, ed. Ultrasound-Assisted Liposuction: Current Concepts and Techniques; Springer International Publishing date 2020; pages 3-8.
  • Jewell ML, Fodor PB, de Souza Pinto EB, Al Shammari MA. Clinical application of VASER--assisted lipoplasty: a pilot clinical study. Aesthet Surg J. 2002 Mar;22(2):131-46. doi: 10.1067/maj.2002.123377. PubMed 19331963 ↗
  • Chang CC, Commons GW. A comparison of various ultrasound technologies. Clin Plast Surg. 1999 Apr;26(2):261-8; viii. PubMed 10327266 ↗
  • Serdev N. Ultrasound Assisted Liposculpture UAL: A Simplified Safe Body Sculpturing and Aesthetic Beautification Technique. 2011.

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers. Study results will be reported in aggregate.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 15, 2026
StartActual
Aug 6, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Apr 30, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07820397
Lead sponsor
Apyx Medical
Responsible party
Sponsor
First posted
Sep 15, 2026
Start date
Aug 6, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Global Senior Director, Clinical Affairs
Contact
research@apyxmedical.com
1-800-537-2790
Paul Vanek, MD
principal investigator · Mentor Plastic Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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