Laser Assisted Liposuction
Conditions
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 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.
Interventions
DEVICELipoLife system
Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.
Sponsors
Alma Lasers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct Identification of Before and After Photographs | 3 months | Over 90% success in correct identification of before and after body contouring photos by blinded evaluators. |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Assisted Liposuction Laser Assisted Liposuction with the LipoLife system.
LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Seven subjects out of the study group underwent facial fat grafting. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Laser Assisted Liposuction |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 44.3 years STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment Israel | 15 participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Correct Identification of Before and After Photographs
Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laser Assisted Liposuction | Correct Identification of Before and After Photographs | 20 Participants |