Clinical Trial: UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Evaluation of the UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)

Brief Summary: Male volunteers who suffer from Pseudogynecomastia and seek noninvasive breast fat reduction will be enrolled into two arms to receive three biweekly UltraShape treatments.

Detailed Summary:

Up to 40 adult male volunteers, who suffer from Pseudogynecomastia, and seek noninvasive breast fat reduction will be enrolled at up to three investigational sites. Eligible subject will be divided into one of the two treatment arms: Arm 1: Subjects will be treated on one side of the breast, while the opposite side will serve as control - Up to 20 subjects; Arm 2: Subjects will be treated on both sides of the breast - Up to 20 subjects. Subjects will receive 3 bi-weekly treatments (at 2-week intervals) with the UltraShape device.

Subjects will return for 3 follow-up visits post last treatment (Tx.3): four weeks follow-up (4wk FU), eight weeks follow-up (8wk FU) and 12 weeks follow-up (12wk FU) for total expected study duration of 16 weeks.


Sponsor: Syneron Medical

Current Primary Outcome: Reduction in breast fat thickness after 3 treatments compared to baseline [ Time Frame: 12 weeks after 3rd treatment (16 weeks) ]

Average reduction in breast fat thickness after 3 treatments compared to baseline, as measured by ultrasound imaging


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in breast fat thickness on treated side compared to control side [ Time Frame: 12 weeks after 3rd treatment (16 weeks) ]
    Average reduction in breast fat thickness on treated side compared to control side, as measured by ultrasound imaging (Arm 1 only)
  • Reduction in breast/chest circumference after 3 treatments compared to baseline [ Time Frame: At 4-week, 8-week and 12-week follow-ups ]
    Average reduction in breast/chest circumference after 3 treatments compared to baseline, as measured by measuring tape (Arm 2 only)
  • Reduction in breast fat thickness compared to baseline [ Time Frame: At 4-week, 8-week and 12-week follow-ups ]
    Average reduction in breast fat thickness compared to baseline, as measured by skin caliper
  • Reduction in breast fat thickness on treated side compared to control side [ Time Frame: At 4-week, 8-week and 12-week follow-ups ]
    Average reduction in breast fat thickness on treated side compared to control side, as measured by skin caliper (Arm 1 only)


Original Secondary Outcome: Same as current

Information By: Syneron Medical

Dates:
Date Received: March 13, 2016
Date Started: July 2017
Date Completion: September 2018
Last Updated: April 5, 2017
Last Verified: April 2017