NCT02711605

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Gynecomastia
• Male Breast Enlargement

Interventions

Type	Name	Description
DEVICE	UltraShape focused ultrasound device	3 biweekly focused ultrasound treatments to the male chest with UltraShape.

Timeline

• Start date: 2016-03-13
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2016-03-17
• Last updated: 2018-08-24

Regulatory

• FDA-regulated device study