Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting Sy… (NCT01791660) | Clinical Trial Compass
UnknownNot Applicable
Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
United States12 participantsStarted 2012-08
Plain-language summary
Protocol is intended for the clinical evaluation of fat reduction in male breasts (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the flanks, and is commercially available.
Primary study endpoint is changes in the shape and reduction of the fat in the breast as established by photographic imaging and ultrasound imaging of the treated area.
Secondary endpoints will provide supportive data to evaluate device performance (subject satisfaction \& fat reduction measured with ultrasound).
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Male subjects \> 18 years of age and \< 70 years of age.
✓. Subject has clearly visible, palpable, excess fatty tissue in their breast area, and minimal fibrous tissue.
✓. Subject has not had weight change exceeding 10 pounds in the preceding month.
✓. Subject agrees to maintain their weight (i.e., within +/- 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
✓. Subject has read and signed a written informed consent form.
Exclusion criteria
✕. Subject has had a surgical procedure(s) in the area of intended treatment.
✕. Subject has had an invasive fat reduction procedure (e.g., liposuction or mesotherapy) in the area of intended treatment.
✕. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment.
✕. Subject needs to administer, or has a known history of, subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
What they're measuring
1
reduction of the fat layer
Timeframe: 8 months
Trial details
NCT IDNCT01791660
SponsorDermatology, Laser & Vein Specialists of the Carolinas
✕. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
✕. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
✕. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
✕. Subject body mass index (BMI) exceeds 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.