Trial Outcomes & Findings for Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System (NCT NCT03800563)
NCT ID: NCT03800563
Last Updated: 2022-10-25
Results Overview
Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
3 months
Results posted on
2022-10-25
Participant Flow
Participant milestones
| Measure |
Laser Assisted Liposuction of Abdominal Excessive Fat
Laser Assisted Liposuction with the LipoLife system. LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Added: "Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery." Seven subjects out of the study group underwent facial fat grafting.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Baseline characteristics by cohort
| Measure |
Laser Assisted Liposuction
n=20 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
|
Region of Enrollment
Israel
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOver 90% success in correct identification of before and after body contouring photos by blinded evaluators.
Outcome measures
| Measure |
Laser Assisted Liposuction
n=20 Participants
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.
|
|---|---|
|
Correct Identification of Before and After Photographs
|
20 Participants
|
Adverse Events
Laser Assisted Liposuction
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Laser Assisted Liposuction
n=20 participants at risk
Laser Assisted Liposuction with the LipoLife system.
LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hematoma
|
5.0%
1/20 • Number of events 1 • Duration of each subject's participation was up to 8 months from enrollment to termination. Adverse events data was to be reported at any time during or after the use of the study device.
Definitions of adverse event and serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov Definitions
|
|
Infections and infestations
urinary track infection
|
5.0%
1/20 • Number of events 1 • Duration of each subject's participation was up to 8 months from enrollment to termination. Adverse events data was to be reported at any time during or after the use of the study device.
Definitions of adverse event and serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov Definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place