Gynecomastia
Conditions
Brief 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).
Detailed description
not desired
Interventions
DEVICEZeltiq Coolsculpting System
Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
Sponsors
Dermatology, Laser & Vein Specialists of the Carolinas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUDED: 1. Male subjects \> 18 years of age and \< 70 years of age. 2. Subject has clearly visible, palpable, excess fatty tissue in their breast area, and minimal fibrous tissue. 3. Subject has not had weight change exceeding 10 pounds in the preceding month. 4. 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. 5. Subject has read and signed a written informed consent form.
Exclusion criteria
EXCLUDED: <!-- --> 1. Subject has had a surgical procedure(s) in the area of intended treatment. 2. Subject has had an invasive fat reduction procedure (e.g., liposuction or mesotherapy) in the area of intended treatment. 3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment. 4. 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. 5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 6. 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. 7. 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. 8. 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. 9. Subject is taking or has taken diet pills or diet supplements within the past month. 10. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation. 11. Subject is unable or unwilling to comply with the study requirements. 12. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 13. Personal history of previous breast malignancy. 14. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject. 15. Subject is taking any medication which could cause abnormal breast enlargement - including but not limited to: digoxin, furosemide, gonadotropins, clomiphene, phenytoin, and exogenous testosterone, ketoconazole, metronidazole, alkylating agents, cisplatin, spironolactone, cimetidine, flutamide, finasteride, etomidate, isonicotinic acid hydrazide, methyldopa, busulfan, tricyclic antidepressants, diazepam, penicillamine, omeprazole, phenothiazines, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors. 16. Recent history (within the past 5 years) of substance abuse (alcohol, marijuana or heroin). 17. Subject has no history of the following medical conditions: Klinefelter syndrome, Congenital anorchia, Testicular trauma, Testicular torsion, Viral orchitis, Kallmann syndrome , Pituitary tumors, Malignancies that increase the serum level of hCG (eg, large cell lung cancer, gastric carcinoma, renal cell carcinoma, hepatoma), Renal failure, Hyperthyroidism, Malnutrition, Androgen insensitivity syndrome, Five-alpha-reductase deficiency syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of the fat layer | 8 months | Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual reduction of the fat layer | 8 months | Subject satisfaction measured by subject questionnaires. |
Countries
United States
Contacts
Primary ContactCindy L Tucker, RN CCRP
Backup ContactRazia Ludin, Research assistant
Outcome results
None listed