Status:
COMPLETED
Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Lead Sponsor:
Alma Lasers
Conditions:
Laser Assisted Liposuction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will i...
Eligibility Criteria
Inclusion
- Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction
- Estimated fat harvesting of 1-3 liters
- Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek
- Between 18 and 70 years of age
- Provided written Informed Consent
Exclusion
- Body Mass Index (BMI) \>35
- Sever skin laxity
- Positive pregnancy test
- 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 prior to enrollment
- Subjects with immune system diseases
- Subject unable to follow post-treatment instructions
- Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Key Trial Info
Start Date :
November 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03800563
Start Date
November 6 2018
End Date
May 20 2020
Last Update
October 25 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanctuary Plastic Surgery
Boca Raton, Florida, United States, 33431
2
Yitzhak Shamir Medical Center
Be’er Ya‘aqov, Israel