Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat

Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat

Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure

Study Overview

• Status: Withdrawn
• Conditions: Laser Assisted Liposuction
• Intervention / Treatment: Device: LipoLife system

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • William Jason Martin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment.
2. Between 18 and 70 years of age.
3. Estimated fat harvesting of at least 300 milliliters.
4. Provided written Informed Consent.

Exclusion Criteria:

1. Pregnant or intending to become pregnant during the course of study.
2. Current smoker.
3. Presence of known malignancy.
4. Active infection in the treatment area.
5. History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]).
6. History of connective, metabolic, or atrophic skin disease.
7. History of keloid scarring.
8. Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
9. Subjects with immune system diseases.
10. Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser-assisted liposuction; Laser-Assisted Liposuction with the LipoLife system.	Device: LipoLife system; Abdominal Laser-Assisted Liposuction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average adipose cell cluster size	Assessment of adipose cell cluster size by microscope	6 months

Collaborators and Investigators

• Sponsor: Alma Lasers
• Investigators: Principal Investigator: William Jason Martin, MD, Jason Martin, M.D.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): February 1, 2023
• Study Completion (Estimated): May 1, 2023

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ALM-Lipo-VorFat-21-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes