Within-Subject Comparison of Adipose Tissue Viability Following Liposuction
9. září 2026 aktualizováno: Apyx Medical
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.
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
30
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Global Senior Director, Clinical Affairs
- Telefonní číslo: 1-800-537-2790
- E-mail: research@apyxmedical.com
Studijní místa
-
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Ohio
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Concord, Ohio, Spojené státy, 44077
- Nábor
- Mentor Plastic Surgery
-
Kontakt:
- Petula Kelly
- Telefonní číslo: 440-205-5750
- E-mail: petula@paulvanekmd.com
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Kontakt:
- Mindy Renick
- Telefonní číslo: 440-205-5750
- E-mail: Mindy@paulvanekmd.com
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Vrchní vyšetřovatel:
- Paul Vanek, MD
-
-
Washington
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Olympia, Washington, Spojené státy, 98506
- Nábor
- Pearl Plastic Surgery
-
Kontakt:
- Shauna Smith-Ewers
- Telefonní číslo: 360-878-9300
- E-mail: shauna@pearlplasticsurgery.com
-
Kontakt:
- Elle Mortensen
- Telefonní číslo: 360-878-9300
- E-mail: elle@pearlplasticsurgery.com
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Vrchní vyšetřovatel:
- Chris Nichols, MD
-
Vrchní vyšetřovatel:
- Dan Albershardt, MD
-
Dílčí vyšetřovatel:
- Owen Johnson, MD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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 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.
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 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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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.
Ostatní jména:
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.
Ostatní jména:
|
|
Aktivní komparátor: 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.
|
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.
Ostatní jména:
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Paired Difference in Adipocyte Viability Between AYON and VASER
Časové okno: Day 1
|
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
|
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Paired Difference in Adipocyte Viability Between Vacuum and Peristaltic Pump Aspiration
Časové okno: Day 1
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Viable adipocyte density (cells/mL)
Časové okno: Day 1
|
Determined by adipocyte counting combined with membrane integrity (live-dead) assessment using Trypan Blue exclusion
|
Day 1
|
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Fat composition analysis
Časové okno: Day 1
|
Quantification of oil, fluid, and viable adipose fractions, as well as free oil fraction
|
Day 1
|
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SVF yield (cells/g fat)
Časové okno: Day 1
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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
|
Day 1
|
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Metabolic activity
Časové okno: Day 1
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Resazurin/Alamar Blue assay results
|
Day 1
|
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Aspiration rate (mL/min) (Arm 2 only)
Časové okno: Day 1
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Calculated as total aspirate volume divided by active aspiration time
|
Day 1
|
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Intraoperative adverse events
Časové okno: Day 1
|
Adverse events occurring during collection of paired adipose tissue samples
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Day 1
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Paul Vanek, MD, Mentor Plastic Surgery
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- Pu LL. Mechanisms of Fat Graft Survival. Ann Plast Surg. 2016 Feb;77 Suppl 1:S84-6. doi: 10.1097/SAP.0000000000000730.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Cimino WW. Ultrasonic surgery: power quantification and efficiency optimization. Aesthet Surg J. 2001 May;21(3):233-41. doi: 10.1067/maj.2001.116006.
- 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.
- 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.
- 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.
- Chang CC, Commons GW. A comparison of various ultrasound technologies. Clin Plast Surg. 1999 Apr;26(2):261-8; viii.
- Serdev N. Ultrasound Assisted Liposculpture UAL: A Simplified Safe Body Sculpturing and Aesthetic Beautification Technique. 2011.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
6. srpna 2026
Primární dokončení (Odhadovaný)
31. prosince 2026
Dokončení studie (Odhadovaný)
30. dubna 2027
Termíny zápisu do studia
První předloženo
3. září 2026
První předloženo, které splnilo kritéria kontroly kvality
9. září 2026
První zveřejněno (Aktuální)
15. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- APX-AY-26-02
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data will not be shared with other researchers.
Study results will be reported in aggregate.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .