An interventional study of UltraShape in Excess Abdominal Fat, sponsored by Syneron Medical. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction.
Study subjects will undergo UltraShape treatments on the abdominal area
This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive abdominal fat reduction.
Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumference will be measured and three successive UltraShape treatments, two weeks interval, will be performed.
The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference will be measured in the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A subject is eligible to participate in the study if he/she meets all the following inclusion criteria:
Exclusion Criteria:
A subject is not eligible for participation in this study if he or she meets any of the following exclusion criteria:
Eligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape device according to the study protocol and user manual. 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, for total expected study duration of 16 weeks
Device: UltraShape
Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
Abdominal fat thickness Reduction
Abdominal fat thickness Reduction post UltraShape treatments at 12 weeks follow-up (12wk FU) versus baseline
Time frame: 16 weeks
Evaluate the safety of the treatment
Evaluate the safety of the treatment with the UltraShape device on abdominal area
Time frame: day 0 until 16 weeks
Abdominal fat thickness reduction as measured by Ultrasound
Abdominal fat thickness reduction as measured by Ultrasound device post UltraShape treatments at all follow-up visits (4wk FU, 8wk FU, and 12wk FU) versus baseline
Time frame: 8wk , 12wk , and 16wk
Abdominal fat thickness reduction as measured by caliper
Abdominal fat thickness reduction as measured by caliper post UltraShape treatments at all follow-up visits (4wk FU, 8wk FU, and 12wk FU) versus baseline
Time frame: 8wk , 12wk , and 16wk
Abdominal circumference reduction
Abdominal circumference reduction post UltraShape treatments at all visits (treatments (pre Tx. 2; pre Tx.3) and follow up (4wk FU, 8wk FU, and 12wk FU)) versus baseline
Time frame: 2 weeks , 4 weeks, 8wk , 12wk , and 16wk
Investigator satisfaction:
Satisfaction assessment will be performed independently by the investigator himself using 5 points Likert scale questionnaire at all follow-up visits (4wk FU, 8wk FU and 12wk FU)
Time frame: 8wk , 12wk , and 16wk
Subject satisfaction:
Satisfaction assessment will be performed independently by the subject himself using 5 points Likert scale questionnaire at all follow-up visits (4wk FU, 8wk FU, and 12wk FU).
Time frame: 8wk , 12wk , and 16wk
Comfort level during treatment:
Comfort assessment will be performed independently by the subject himself using a numerical scale. The subjects will answer this questionnaire after each of the three treatments
Time frame: day 0 , 2 weeks , 4 weeks
Plan to share: Undecided
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Syneron Medical