WithdrawnNot Applicable

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

Stopped: Study never got underway due to sponsor re-organization.

0Started 2016-03-13

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent to participate in the study
✓. Male subjects, 18 -70 years of age at the time of enrollment
✓. BMI interval: BMI ≥ 22 and ≤30 (normal to overweight, but not obese)
✓. Fat thickness of at least 1.5 cm in the treated area (breast) as measured by calibrated caliper.
✓. Subject has clearly visible, palpable, excess fatty tissue in their breast area, and minimal fibrous tissue.
✓. Subject agrees to maintain their weight (i.e., within 3% weight change) by not making any major changes in their diet or lifestyle during the course of the study.
✓. General good health confirmed by medical history and skin examination of the treated area.
✓. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.

Exclusion criteria

✕. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator.
✕. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
✕. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
✕. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
✕. Previous body contouring procedures in the treatment area within 12 months.
✕. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.

What they're measuring

Reduction in breast fat thickness after 3 treatments compared to baseline

Timeframe: 12 weeks after 3rd treatment (16 weeks)

Trial details

NCT IDNCT02711605

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-06

View on ClinicalTrials.gov More Gynecomastia trials