Clinical Trial: Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System

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).


Detailed Summary: not desired
Sponsor: Dermatology, Laser & Vein Specialists of the Carolinas

Current Primary Outcome: reduction of the fat layer [ Time Frame: 8 months ]

Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast.


Original Primary Outcome: Same as current

Current Secondary Outcome: visual reduction of the fat layer [ Time Frame: 8 months ]

Subject satisfaction measured by subject questionnaires.


Original Secondary Outcome: Same as current

Information By: Dermatology, Laser & Vein Specialists of the Carolinas

Dates:
Date Received: August 31, 2012
Date Started: August 2012
Date Completion: April 2013
Last Updated: February 12, 2013
Last Verified: February 2013