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Clinical Trials/NCT05016674
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

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

Registry
clinicaltrials.gov
Start Date
July 21, 2021
End Date
May 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Alma Lasers
Responsible Party
Sponsor

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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