Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System|
- reduction of the fat layer [ Time Frame: 8 months ] [ Designated as safety issue: No ]Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast.
- visual reduction of the fat layer [ Time Frame: 8 months ] [ Designated as safety issue: No ]Subject satisfaction measured by subject questionnaires.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Zeltiq Coolsculpting System
non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
Device: Zeltiq Coolsculpting System
Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
|Contact: Cindy L Tucker, RN CCRP||704-375-6766 ext firstname.lastname@example.org|
|Contact: Razia Ludin, Research assistant||704-375-6766 ext email@example.com|
|United States, North Carolina|
|Dermatology, Laser & Vein Specialists of the Carolinas||Recruiting|
|Charlotte, North Carolina, United States, 28207|
|Contact: Cindy L Tucker, RN CCRP 704-375-6766 ext 3537 firstname.lastname@example.org|
|Contact: Razia Ludin, research assistant 704-375-6766 ext 3606 email@example.com|
|Principal Investigator: Girish S Munavalli, MD MHS|
|Principal Investigator:||Girish S Munavalli, MD MHS||Dermatology, Laser & Vein Specialists of the Carolinas|