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 range

18 Years – 70 Years

Sex

MALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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