N/A N=20 Treatment

Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

Laser Assisted Liposuction

Bottom Line

View on ClinicalTrials.gov: NCT03800563 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Correct Identification of Before and After Photographs — 20 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LipoLife system (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alma Lasers
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Correct Identification of Before and After Photographs	20	—

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 include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03800563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.