Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02711618
Brief Summary:
Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction.
The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.
Detailed Description:
This study is a prospective, one arm, up to four sites, clinical study showing the performance and safety of the UltraShape contour I V3 device non-invasive abdominal fat reduction for subjects with body mass index (BMI) above 28.
Up to 60 healthy subjects will be enrolled. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumferences will be measured and three successive UltraShape contour I V3 treatments will be performed (two weeks interval).
Subjects will undergo treatment with the UltraShape contour I V3 using the U-Sculpt/VDF transducer on the abdomen area.
Follow-up (FU) visits will be conducted as follows: 4 weeks FU, 8 weeks FU and 12 weeks FU post last treatment (Tx.3). Subject's fat thickness and circumference will be measured at each visit. Subject's blood test will be taken at baseline (prior to the first treatment, pre Tx.1), before the third treatment (pre Tx.3) and at 12 weeks follow-up visit (12wk FU). "No Pregnancy" will be verified before first treatment as well. In all following visits (TX2, Tx3 and FU 1 FU 2 and FU3), lack of pregnancy will be verified by questioning. Additionally, subject satisfaction and investigator satisfaction questionnaires will be completed at each FU visit. Finally, photography will be performed under visible light conditions of the front, right and left view. Optional, 3D photographs will be taken at each visit (at treatment visits, prior to treatments).
Study:
NCT02711618
Study Brief:
Protocol Section:
NCT02711618