NCT05016674
Unknown
Not Applicable
Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat
Alma Lasers1 site in 1 country3 target enrollmentJuly 21, 2021
ConditionsLaser Assisted Liposuction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laser Assisted Liposuction
- Sponsor
- Alma Lasers
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Average adipose cell cluster size
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Between 18 and 70 years of age.
- •Estimated fat harvesting of at least 300 milliliters.
- •Provided written Informed Consent.
Exclusion Criteria
- •Pregnant or intending to become pregnant during the course of study.
- •Current smoker.
- •Presence of known malignancy.
- •Active infection in the treatment area.
- •History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\]).
- •History of connective, metabolic, or atrophic skin disease.
- •History of keloid scarring.
- •Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
- •Subjects with immune system diseases.
- •Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.
Outcomes
Primary Outcomes
Average adipose cell cluster size
Time Frame: 6 months
Assessment of adipose cell cluster size by microscope
Study Sites (1)
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