Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-21 @ 6:09 PM
Study NCT ID:
NCT02711605
Status:
WITHDRAWN
Last Update Posted:
2018-08-24
First Post:
2016-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
Sponsor:
Syneron Medical
Organization:
Study Overview
Official Title:
Clinical Evaluation of the UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never got underway due to sponsor re-organization.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: