Within-Subject Comparison of Adipose Tissue Viability Following Liposuction
2026년 9월 9일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
30
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Global Senior Director, Clinical Affairs
- 전화번호: 1-800-537-2790
- 이메일: research@apyxmedical.com
연구 장소
-
-
Ohio
-
Concord, Ohio, 미국, 44077
- 모병
- Mentor Plastic Surgery
-
연락하다:
- Petula Kelly
- 전화번호: 440-205-5750
- 이메일: petula@paulvanekmd.com
-
연락하다:
- Mindy Renick
- 전화번호: 440-205-5750
- 이메일: Mindy@paulvanekmd.com
-
수석 연구원:
- Paul Vanek, MD
-
-
Washington
-
Olympia, Washington, 미국, 98506
- 모병
- Pearl Plastic Surgery
-
연락하다:
- Shauna Smith-Ewers
- 전화번호: 360-878-9300
- 이메일: shauna@pearlplasticsurgery.com
-
연락하다:
- Elle Mortensen
- 전화번호: 360-878-9300
- 이메일: elle@pearlplasticsurgery.com
-
수석 연구원:
- Chris Nichols, MD
-
수석 연구원:
- Dan Albershardt, MD
-
부수사관:
- Owen Johnson, MD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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.
다른 이름들:
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.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Paired Difference in Adipocyte Viability Between AYON and VASER
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Viable adipocyte density (cells/mL)
기간: 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
기간: Day 1
|
Quantification of oil, fluid, and viable adipose fractions, as well as free oil fraction
|
Day 1
|
|
SVF yield (cells/g fat)
기간: 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
기간: Day 1
|
Resazurin/Alamar Blue assay results
|
Day 1
|
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Aspiration rate (mL/min) (Arm 2 only)
기간: Day 1
|
Calculated as total aspirate volume divided by active aspiration time
|
Day 1
|
|
Intraoperative adverse events
기간: Day 1
|
Adverse events occurring during collection of paired adipose tissue samples
|
Day 1
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Paul Vanek, MD, Mentor Plastic Surgery
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 6일
기본 완료 (추정된)
기본 완료
2026년 12월 31일
연구 완료 (추정된)
연구 완료
2027년 4월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 9월 3일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 9월 9일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- APX-AY-26-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared with other researchers.
Study results will be reported in aggregate.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
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예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .