Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-06 @ 2:40 AM
Study NCT ID:
NCT02939105
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CoolSculpting Treatment in the Upper Arms
Sponsor:
Zeltiq Aesthetics
Organization:
Study Overview
Official Title:
DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
Status:
COMPLETED
Status Verified Date:
2021-05
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:
ARM
Brief Summary:
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.
Detailed Description:
Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: