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.
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
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
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- 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.
United States2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Ultrasound-Assisted Liposuction Comparison | Active comparator | 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. Receives: Device: AYON Ultrasound-Assisted Liposuction System; Device: VASER Ultrasound-Assisted Liposuction System |
| Aspiration Modality Comparison | Active comparator | 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. 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.
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
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)
Viable adipocyte density (cells/mL)
Determined by adipocyte counting combined with membrane integrity (live-dead) assessment using Trypan Blue exclusion
Measured: Day 1
Fat composition analysis
Quantification of oil, fluid, and viable adipose fractions, as well as free oil fraction
Measured: Day 1
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
Metabolic activity
Resazurin/Alamar Blue assay results
Measured: Day 1
Aspiration rate (mL/min) (Arm 2 only)
Calculated as total aspirate volume divided by active aspiration time
Measured: Day 1
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.
- First posted15 Sep 2026
- Study start6 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for LiposuctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Apyx Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Vanek, MD, Principal investigator, Mentor Plastic Surgery
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 26808753Fontes 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 30505441Mojallal 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 19065021Yoshimura 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 19317645Molitor 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 33876289Coleman 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 16936550Fisher 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 23584621Shiffman 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 11553171Eto 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 19935292Kurita 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 18317153Rohrich 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 14707664Shauly 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 35317456Ruff 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 37441115Cimino WW. Ultrasonic surgery: power quantification and efficiency optimization. Aesthet Surg J. 2001 May;21(3):233-41. doi: 10.1067/maj.2001.116006.
PubMed 19331898Kloehn RA. Liposuction With "Sonic Sculpture": Six Years' Experience With More Than 600 Patients. Aesthetic Surgery Journal. 1996/01/01/ 1996;16(2):123-128