Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol. Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
Skin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, United States
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
Time frame: At 12 weeks after the third treatment (week 16) for each subject
Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline. The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively). Negative change represent reduction in thigh circumference.
Time frame: At 2, 4, 8 and 12 weeks after baseline
Investigator Satisfaction
Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)
Time frame: At 4, 8 and 12 weeks follow-up visits
Subject Satisfaction
Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).
Time frame: At 4, 8 and 12 week follow-up visits
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