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出境医 / 临床实验 / UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)

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

Study Description
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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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)
Actual Study Start Date : March 13, 2016
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Sponsors and Collaborators
Syneron Medical
Investigators
Layout table for investigator information
Study Director: Shlomit Mann, MA Syneron Medical
Tracking Information
First Submitted Date  ICMJE March 13, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date August 24, 2018
Actual Study Start Date  ICMJE March 13, 2016
Actual Primary Completion Date December 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2016) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2016)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2016) 		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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
Official Title  ICMJE Clinical Evaluation of the UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Gynecomastia
  • Male Breast Enlargement
Intervention  ICMJE Device: UltraShape focused ultrasound device
3 biweekly focused ultrasound treatments to the male chest with UltraShape.
Other Name: Contour I
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 22, 2018) 		0
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2016) 		40
Actual Study Completion Date  ICMJE December 6, 2017
Actual Primary Completion Date December 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02711605
Other Study ID Numbers  ICMJE DHF21271
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Syneron Medical
Study Sponsor  ICMJE Syneron Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shlomit Mann, MA Syneron Medical
PRS Account Syneron Medical
Verification Date August 2018

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

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