Excess Abdominal Fat Clinical Trial
Official title:
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat Reduction
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03502473 -
UltraShape Power Device for Fat Reduction in Flanks
|
N/A | |
| Completed |
NCT02748928 -
UltraShape Power for Abdominal Fat and Circumference Reduction
|
N/A |