NCT01791660

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Dermatology, Laser & Vein Specialists of the Carolinas · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 description

not desired

Conditions

• Gynecomastia

Interventions

Type	Name	Description
DEVICE	Zeltiq Coolsculpting System	Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-02-15
• Last updated: 2013-02-15

Locations

1 site across 1 country: United States