Within-Subject Comparison of Adipose Tissue Viability Following Liposuction

NCT07820397 | Recruiting FDA Device

• 1 other identifier: APX-AY-26-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1

Secondary Outcomes (6)

• Viable adipocyte density (cells/mL)

  Day 1

• Fat composition analysis

  Day 1

• SVF yield (cells/g fat)

  Day 1

• Metabolic activity

  Day 1

• Aspiration rate (mL/min) (Arm 2 only)

  Day 1

Study Arms (2)

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.

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.

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

Interventions

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.

Also known as: AYON UAL System, AYON

Ultrasound-Assisted Liposuction Comparison

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.

Also known as: VASER

Ultrasound-Assisted Liposuction Comparison

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.

Also known as: AYON PL, AYON PL System

Aspiration Modality Comparison

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.

Aspiration Modality Comparison

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (2)

Mentor Plastic Surgery

Concord, Ohio, 44077, United States

RECRUITING

Pearl Plastic Surgery

Olympia, Washington, 98506, United States

RECRUITING

Related Publications (22)

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

  PMID: 26808753 BACKGROUND

• 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.

  PMID: 30505441 BACKGROUND

• 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.

  PMID: 19065021 BACKGROUND

• 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.

  PMID: 19317645 BACKGROUND

• 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.

  PMID: 33876289 BACKGROUND

• 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.

  PMID: 16936550 BACKGROUND

• 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.

  PMID: 23584621 BACKGROUND

• 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.

  PMID: 11553171 BACKGROUND

• 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.

  PMID: 19935292 BACKGROUND

• 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.

  PMID: 18317153 BACKGROUND

• 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.

  PMID: 14707664 BACKGROUND

• 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.

  PMID: 35317456 BACKGROUND

• 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.

  PMID: 37441115 BACKGROUND

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

  PMID: 19331898 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 10839419 BACKGROUND

• 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.

  PMID: 9426668 BACKGROUND

• Garcia O. Ultrasound-Assisted Liposuction Current Concepts and Techniques: Current Concepts and Techniques. 2020.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19331963 BACKGROUND

• Chang CC, Commons GW. A comparison of various ultrasound technologies. Clin Plast Surg. 1999 Apr;26(2):261-8; viii.

  PMID: 10327266 RESULT

• Serdev N. Ultrasound Assisted Liposculpture UAL: A Simplified Safe Body Sculpturing and Aesthetic Beautification Technique. 2011.

  RESULT

MeSH Terms

Interventions

Vacuum Curettage

Intervention Hierarchy (Ancestors)

Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Paul Vanek, MD

  Mentor Plastic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Global Senior Director, Clinical Affairs

CONTACT

1-800-537-2790; research@apyxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 15, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)