Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02143960
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction
Sponsor:
Syneron Medical
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Performance of the VelaShape III Device in Comparison to Cryolipolysis for Reduction in Waist / Love Handles / Flanks.
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
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:
The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
Detailed Description:
VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.
The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.
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?: