ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02711605
Recruitment Status : Withdrawn (Study never got underway due to sponsor re-organization.)
First Posted : March 17, 2016
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

March 13, 2016
March 17, 2016
August 24, 2018
March 13, 2016
December 6, 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02711605 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • 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
  • 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)
Same as current
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
Same as current
 
UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
Clinical Evaluation of the UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
Male volunteers who suffer from Pseudogynecomastia and seek noninvasive breast fat reduction will be enrolled into two arms to receive three biweekly UltraShape treatments.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Gynecomastia
  • Male Breast Enlargement
Device: UltraShape focused ultrasound device
3 biweekly focused ultrasound treatments to the male chest with UltraShape.
Other Name: Contour I
  • 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.
    Intervention: Device: UltraShape focused ultrasound device
  • Experimental: Bilateral UltraShape treatment
    Both sides of the chest (right and left breasts) will be treated with the UltraShape focused ultrasound device.
    Intervention: Device: UltraShape focused ultrasound device
Moreno-Moraga J, Valero-Altés T, Riquelme AM, Isarria-Marcosy MI, de la Torre JR. Body contouring by non-invasive transdermal focused ultrasound. Lasers Surg Med. 2007 Apr;39(4):315-23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
40
December 6, 2017
December 6, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT02711605
DHF21271
No
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
Plan to Share IPD: Undecided
Syneron Medical
Syneron Medical
Not Provided
Study Director: Shlomit Mann, MA Syneron Medical
Syneron Medical
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP