Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape device for non-invasive abdominal fat and circumference reduction. Study subjects will undergo SlimShape treatments on the abdominal area.
The objective of this trial is to evaluate the safety and efficacy of the SlimShape device utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference reduction. Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval) with the SlimShape device utilizing the SlimShape Applicator Belt according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment. Each subject will be enrolled for total expected study duration of up to 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
SlimShape radiofrequency treatment to the abdomen
Laser & Skin Surgery Medical Group, Inc
Sacramento, California, United States
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, United States
Union Square Laser Dermatology
New York, New York, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Change in Fat Thickness at Final Follow-up Compared to Baseline
Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline
Time frame: Baseline and 12 weeks follow-up
Change in Fat Thickness After Treatments Compared to Baseline
Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline
Time frame: Baseline and 4 and 8 weeks follow-up
Change in Abdominal Circumference After Treatments Compared to Baseline
Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline
Time frame: At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)
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