Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT01791660
Status:
UNKNOWN
Last Update Posted:
2013-02-15
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
Sponsor:
Dermatology, Laser & Vein Specialists of the Carolinas
Organization:
Study Overview
Official Title:
Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
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:
Protocol is intended for the clinical evaluation of fat reduction in male breasts (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the flanks, and is commercially available.
Primary study endpoint is changes in the shape and reduction of the fat in the breast as established by photographic imaging and ultrasound imaging of the treated area.
Secondary endpoints will provide supportive data to evaluate device performance (subject satisfaction \& fat reduction measured with ultrasound).
Primary study endpoint is changes in the shape and reduction of the fat in the breast as established by photographic imaging and ultrasound imaging of the treated area.
Secondary endpoints will provide supportive data to evaluate device performance (subject satisfaction \& fat reduction measured with ultrasound).
Detailed Description:
not desired
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?: