Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT02711618
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Abdominal Fat Reduction With BMI Above 28
Sponsor:
Syneron Medical
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Performance of the UltraShape Contour I V3 for Non-Invasive Abdominal Fat Reduction Among Patients With BMI Above 28
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: