Recruiting

Coolsculpting

Sponsor:

Dermatology, Laser & Vein Specialists of the Carolinas

Code:

NCT01791660

Conditions

Gynecomastia

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Zeltiq Coolsculpting System

Study Details

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).

Conditions

Gynecomastia

Study ID

NCT01791660

Start date

Aug, 2012

Status verified date

Feb, 2013

Completion date

Apr, 2013

Anticipated

Primary completion date

Apr, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Accepted

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:

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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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zeltiq Coolsculpting System

non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Interventions

Zeltiq Coolsculpting System

Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Primary outcome measure

  • reduction of the fat layer [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Razia Ludin, Research assistant

704-375-6766razial@carolinaskin.com

Locations

Dermatology, Laser & Vein Specialists of the Carolinas

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Razia Ludin, research assistant

704-375-6766razial@carolinaskin.com

Principal Investigator:

Girish S Munavalli, MD MHS

More Information

Sponsor

Dermatology, Laser & Vein Specialists of the Carolinas

Last update posted

Feb 15, 2013

Last verified

Feb, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dermatology, Laser & Vein Specialists of the Carolinas on 2013-02-15.