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Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat

Not Applicable
Conditions
Laser Assisted Liposuction
Interventions
Device: LipoLife system
Registration Number
NCT05016674
Lead Sponsor
Alma Lasers
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
3
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Laser-assisted liposuctionLipoLife systemLaser-Assisted Liposuction with the LipoLife system.
Primary Outcome Measures
NameTimeMethod
Average adipose cell cluster size6 months

Assessment of adipose cell cluster size by microscope

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

William Jason Martin, MD

🇺🇸

Denver, Colorado, United States

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