UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.
UltraShape Device for Thigh Fat and Circumference Reduction- Up to 60 healthy adult volunteers seeking for noninvasive thighs circumference reduction, male and females, 18 to 60 years of age from up to four investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) on one randomized thigh with the UltraShape device according to the study protocol. The other thigh will not be treated during the main study phase (and serve as control). The subjects will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment. Total expected study duration: 20-22 weeks. Should the subject choose to receive additional optional treatments on the untreated side, up to three bi-weekly treatments will be performed upon study completion at no cost to the subject while changing total study duration to 24-26 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
circumference reduction
Coleman Center for Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States
RECRUITINGMaryland Laser, Skin, & Vein Institute
Baltimore, Maryland, United States
RECRUITINGSkin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, United States
COMPLETEDevaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction
Time frame: 8 weeks up to 20 weeks
safety issues assessed by The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)
Time frame: day 0 up to 20 weeks
thigh circumference reduction
significant thigh circumference reduction post UltraShape treatments. Reduction will be calculated at each follow-up visit (4wk FU, 8wk FU and 16wk FU) versus baseline and versus control thigh.
Time frame: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment,
thigh fat thickness reduction by ultrasound
fat thickness reduction post UltraShape treatments as measured by caliper and by Ultrasound device
Time frame: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks
thigh fat thickness reduction by caliper
thigh fat thickness reduction
Time frame: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks
Subject satisfaction by questionnaire
Satisfaction assessment will be performed independently by the subject himself
Time frame: 8 weeks, 12 weeks, 20 weeks
Comfort level by NSR scale
Comfort level during treatment will be performed post each treatment
Time frame: day 0, 2 weeks, 4 weeks
Investigator satisfaction by questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
assessment comparing before and after photos using the 5-Point Likert Scale
Time frame: 8 weeks, 12 weeks, 20 weeks