Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat

Laser Assisted Liposuction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05016674
• Other study ID #: ALM-Lipo-VorFat-21-013
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: July 2022
• Source: Alma Lasers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: May 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laser Assisted Liposuction

Intervention

Device:
• LipoLife system
Abdominal Laser-Assisted Liposuction

Locations

Country	Name	City	State
United States	William Jason Martin, MD	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average adipose cell cluster size	Assessment of adipose cell cluster size by microscope	6 months