GynecomastiaNCT02711605
UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
A study testing UltraShape focused ultrasound device in people with Gynecomastia and Male Breast Enlargement, run by Syneron Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecomastia, Male Breast Enlargement
- What is being tested?
- UltraShape focused ultrasound device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2016to 6 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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).
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
- Personal history of previous breast malignancy.
- 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.
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecomastia, Male Breast Enlargement
- Being tested
- UltraShape focused ultrasound device
- Keywords
- ultrasound, fat
- Medical subject headings
- Gynecomastia, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShape focused ultrasound deviceDevice
Also called Contour I
3 biweekly focused ultrasound treatments to the male chest with UltraShape.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: UltraShape focused ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks after 3rd treatment (16 weeks)
Secondary outcomes (4)
Reduction in breast fat thickness on treated side compared to control side
Average reduction in breast fat thickness on treated side compared to control side, as measured by ultrasound imaging (Arm 1 only)
Measured: 12 weeks after 3rd treatment (16 weeks)
Reduction in breast/chest circumference after 3 treatments compared to baseline
Average reduction in breast/chest circumference after 3 treatments compared to baseline, as measured by measuring tape (Arm 2 only)
Measured: At 4-week, 8-week and 12-week follow-ups
Reduction in breast fat thickness compared to baseline
Average reduction in breast fat thickness compared to baseline, as measured by skin caliper
Measured: At 4-week, 8-week and 12-week follow-ups
Reduction in breast fat thickness on treated side compared to control side
Average reduction in breast fat thickness on treated side compared to control side, as measured by skin caliper (Arm 1 only)
Measured: At 4-week, 8-week and 12-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start13 Mar 2016
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Why it stopped: Study never got underway due to sponsor re-organization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Mann, MA, Study director, Syneron Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711605
- Sponsor's protocol ID
- DHF21271
- Status last verified
- Aug 2018
- First submitted
- 13 Mar 2016
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 17457840
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)
- ClinicalTrials.gov ID
- NCT02711605
- Acronym / sponsor ID
- DHF21271
- Conditions
- Gynecomastia, Male Breast Enlargement
- Keywords
- ultrasound, fat
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never got underway due to sponsor re-organization.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2016 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral UltraShape treatment | Experimental | Device: UltraShape focused ultrasound deviceOne 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. |
| Bilateral UltraShape treatment | Experimental | Device: UltraShape focused ultrasound deviceBoth sides of the chest (right and left breasts) will be treated with the UltraShape focused ultrasound device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltraShape focused ultrasound deviceAlso: Contour I3 biweekly focused ultrasound treatments to the male chest with UltraShape. | Device | Bilateral UltraShape treatment, Unilateral UltraShape treatment |
Primary outcome
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
4 secondary outcomes
Reduction in breast fat thickness on treated side compared to control side
Time frame: 12 weeks after 3rd treatment (16 weeks)
Reduction in breast/chest circumference after 3 treatments compared to baseline
Time frame: At 4-week, 8-week and 12-week follow-ups
Reduction in breast fat thickness compared to baseline
Time frame: At 4-week, 8-week and 12-week follow-ups
Reduction in breast fat thickness on treated side compared to control side
Time frame: At 4-week, 8-week and 12-week follow-ups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 17457840Moreno-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Mann, MA study director
Syneron Medical
Questions about this trial
What is this clinical trial studying?
A study testing UltraShape focused ultrasound device in people with Gynecomastia and Male Breast Enlargement, run by Syneron Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in breast fat thickness after 3 treatments compared to baseline (time frame: 12 weeks after 3rd treatment (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.