ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Recruiting, Not yet recruiting, Available Studies | "Gynecomastia"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02711605
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Gynecomastia Male Breast Enlargement Device: UltraShape focused ultrasound device Not Applicable

Detailed Description:

Up to 40 adult male volunteers, who suffer from Pseudogynecomastia, and seek noninvasive breast fat reduction will be enrolled at up to three investigational sites. Eligible subject will be divided into one of the two treatment arms: Arm 1: Subjects will be treated on one side of the breast, while the opposite side will serve as control - Up to 20 subjects; Arm 2: Subjects will be treated on both sides of the breast - Up to 20 subjects. Subjects will receive 3 bi-weekly treatments (at 2-week intervals) with the UltraShape device.

Subjects will return for 3 follow-up visits post last treatment (Tx.3): four weeks follow-up (4wk FU), eight weeks follow-up (8wk FU) and 12 weeks follow-up (12wk FU) for total expected study duration of 16 weeks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Unilateral UltraShape treatment
One side of the chest (left or right breast) will be treated with the UltraShape focused ultrasound device, while the opposite will serve as an untreated control.
Device: UltraShape focused ultrasound device
3 biweekly focused ultrasound treatments to the male chest with UltraShape.
Other Name: Contour I

Experimental: Bilateral UltraShape treatment
Both sides of the chest (right and left breasts) will be treated with the UltraShape focused ultrasound device.
Device: UltraShape focused ultrasound device
3 biweekly focused ultrasound treatments to the male chest with UltraShape.
Other Name: Contour I




Primary Outcome Measures :
  1. Reduction in breast fat thickness after 3 treatments compared to baseline [ Time Frame: 12 weeks after 3rd treatment (16 weeks) ]
    Average reduction in breast fat thickness after 3 treatments compared to baseline, as measured by ultrasound imaging


Secondary Outcome Measures :
  1. Reduction in breast fat thickness on treated side compared to control side [ Time Frame: 12 weeks after 3rd treatment (16 weeks) ]
    Average reduction in breast fat thickness on treated side compared to control side, as measured by ultrasound imaging (Arm 1 only)

  2. Reduction in breast/chest circumference after 3 treatments compared to baseline [ Time Frame: At 4-week, 8-week and 12-week follow-ups ]
    Average reduction in breast/chest circumference after 3 treatments compared to baseline, as measured by measuring tape (Arm 2 only)

  3. Reduction in breast fat thickness compared to baseline [ Time Frame: At 4-week, 8-week and 12-week follow-ups ]
    Average reduction in breast fat thickness compared to baseline, as measured by skin caliper

  4. Reduction in breast fat thickness on treated side compared to control side [ Time Frame: At 4-week, 8-week and 12-week follow-ups ]
    Average reduction in breast fat thickness on treated side compared to control side, as measured by skin caliper (Arm 1 only)


Other Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: through study duration up to 1 year ]
    The number of adverse events, severity, intervention and outcome, as reported on adverse event forms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed informed consent to participate in the study
  2. Male subjects, 18 -70 years of age at the time of enrollment
  3. BMI interval: BMI ≥ 22 and ≤30 (normal to overweight, but not obese)
  4. Fat thickness of at least 1.5 cm in the treated area (breast) as measured by calibrated caliper.
  5. Subject has clearly visible, palpable, excess fatty tissue in their breast area, and minimal fibrous tissue.
  6. 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.
  7. General good health confirmed by medical history and skin examination of the treated area.
  8. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
  9. Willing to have photographs and images taken of the treated areas to be used, de-identified in evaluations, publications and presentations.

Exclusion Criteria:

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator.
  2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
  3. 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.
  4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
  6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
  7. Previous body contouring procedures in the treatment area within 12 months.
  8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
  9. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
  10. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area.
  11. Very poor skin quality (i.e., severe laxity) according to the investigator decision.
  12. Obesity (BMI >30).
  13. Unstable weight within the last 6 months (i.e., 3% weight change in the prior six months).
  14. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
  15. Fat thickness lower than 2.5 cm after strapping at the treated area.
  16. Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).
  17. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
  18. Personal history of previous breast malignancy.
  19. 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.
  20. Subject has 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711605


Contacts
Contact: Girish S Munavalli, M.D. 704-375-6766
Contact: Cindy Tucker, R.N. 704-375-6766 ext 3537 Nurse@carolinaskin.com

Locations
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas Recruiting
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Syneron Medical
Investigators
Principal Investigator: Girish S Munavalli, M.D. Dermatology, Laser & Vein Specialists of the Carolinas

Publications:
Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02711605     History of Changes
Other Study ID Numbers: DHF21271
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Syneron Medical:
ultrasound
fat

Additional relevant MeSH terms:
Hypertrophy
Gynecomastia
Pathological Conditions, Anatomical
Breast Diseases
Skin Diseases