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Within-Subject Comparison of Adipose Tissue Viability Following Liposuction

9. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Concord, Ohio, Vereinigte Staaten, 44077
        • Rekrutierung
        • Mentor Plastic Surgery
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Paul Vanek, MD
    • Washington
      • Olympia, Washington, Vereinigte Staaten, 98506
        • Rekrutierung
        • Pearl Plastic Surgery
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Chris Nichols, MD
        • Hauptermittler:
          • Dan Albershardt, MD
        • Unterermittler:
          • Owen Johnson, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Gerät: AYON 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.
Andere Namen:
  • AYON UAL System
  • AYON
Gerät: VASER 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.
Andere Namen:
  • VASER
Aktiver Komparator: 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.
Gerät: AYON 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.
Andere Namen:
  • AYON PL
  • AYON PL System
Gerät: Vacuum 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Paired Difference in Adipocyte Viability Between AYON and VASER
Zeitfenster: 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
Paired Difference in Adipocyte Viability Between Vacuum and Peristaltic Pump Aspiration
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Viable adipocyte density (cells/mL)
Zeitfenster: Day 1
Determined by adipocyte counting combined with membrane integrity (live-dead) assessment using Trypan Blue exclusion
Day 1
Fat composition analysis
Zeitfenster: Day 1
Quantification of oil, fluid, and viable adipose fractions, as well as free oil fraction
Day 1
SVF yield (cells/g fat)
Zeitfenster: Day 1
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
Metabolic activity
Zeitfenster: Day 1
Resazurin/Alamar Blue assay results
Day 1
Aspiration rate (mL/min) (Arm 2 only)
Zeitfenster: Day 1
Calculated as total aspirate volume divided by active aspiration time
Day 1
Intraoperative adverse events
Zeitfenster: Day 1
Adverse events occurring during collection of paired adipose tissue samples
Day 1

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Apyx Medical

Ermittler

  • Hauptermittler: Paul Vanek, MD, Mentor Plastic Surgery

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. August 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

30. April 2027

Studienanmeldedaten

Zuerst eingereicht

3. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. September 2026

Zuerst gepostet (Tatsächlich)

15. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • APX-AY-26-02

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared with other researchers. Study results will be reported in aggregate.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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