Gynecomastia Clinical Trial
Official title:
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).
not desired ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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