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

NCT02711605 | Withdrawn FDA Device

• 1 other identifier: DHF21271
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gynecomastia; Male Breast Enlargement

Keywords

ultrasound; fat

Outcome Measures

Primary Outcomes (1)

• Reduction in breast fat thickness after 3 treatments compared to baseline

  Average reduction in breast fat thickness after 3 treatments compared to baseline, as measured by ultrasound imaging

  12 weeks after 3rd treatment (16 weeks)

Secondary Outcomes (4)

• Reduction in breast fat thickness on treated side compared to control side

  12 weeks after 3rd treatment (16 weeks)

• Reduction in breast/chest circumference after 3 treatments compared to baseline

  At 4-week, 8-week and 12-week follow-ups

• Reduction in breast fat thickness compared to baseline

  At 4-week, 8-week and 12-week follow-ups

• Reduction in breast fat thickness on treated side compared to control side

  At 4-week, 8-week and 12-week follow-ups

Other Outcomes (1)

• Number of participants with adverse events

  through study duration up to 1 year

Study Arms (2)

Unilateral UltraShape treatment

EXPERIMENTAL

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

Bilateral UltraShape treatment

EXPERIMENTAL

Both sides of the chest (right and left breasts) will be treated with the UltraShape focused ultrasound device.

Device: UltraShape focused ultrasound device

Interventions

UltraShape focused ultrasound device DEVICE

3 biweekly focused ultrasound treatments to the male chest with UltraShape.

Also known as: Contour I

Bilateral UltraShape treatment; Unilateral UltraShape treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator.
• Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
• 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.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
• Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
• Previous body contouring procedures in the treatment area within 12 months.
• History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
• 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.
• 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.
• Very poor skin quality (i.e., severe laxity) according to the investigator decision.
• Obesity (BMI \>30).
• Unstable weight within the last 6 months (i.e., 3% weight change in the prior six months).
• Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
• Fat thickness lower than 2.5 cm after strapping at the treated area.

Sponsors & Collaborators

• Syneron Medical: lead

Related Publications (1)

• Moreno-Moraga J, Valero-Altes 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. doi: 10.1002/lsm.20478.

  PMID: 17457840 BACKGROUND

MeSH Terms

Conditions

Gynecomastia; Platelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shlomit Mann, MA

  Syneron Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: March 17, 2016
• Study Start: March 13, 2016
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08