GynecomastiaNCT01791660
Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
A study testing Zeltiq Coolsculpting System in people with Gynecomastia, run by Dermatology, Laser & Vein Specialists of the Carolinas at 1 site in United States.
Trial summary
Protocol is intended for the clinical evaluation of fat reduction in male breasts (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the flanks, and is commercially available. 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
- What is being tested?
- Zeltiq Coolsculpting System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2013
- 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
- INCLUDED:
- Male subjects > 18 years of age and < 70 years of age.
- Subject has clearly visible, palpable, excess fatty tissue in their breast area, and minimal fibrous tissue.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject agrees to maintain their weight (i.e., within +/- 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Who cannot join
- EXCLUDED:
- <!-- -->
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction or mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment.
- Subject needs to administer, or has a known history of, subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
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- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject body mass index (BMI) exceeds 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject is taking or has taken diet pills or diet supplements within the past month.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Personal history of previous breast malignancy.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
- 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.
- Recent history (within the past 5 years) of substance abuse (alcohol, marijuana or heroin).
- Subject has no 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Cindy L Tucker, RN CCRP, 704-375-6766 ext. 3537, nurse@carolinaskin.com
Razia Ludin, research assistant, 704-375-6766 ext. 3606, razial@carolinaskin.com
About this study
Protocol is intended for the clinical evaluation of fat reduction in male breasts (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the flanks, and is commercially available.
Primary study endpoint is changes in the shape and reduction of the fat in the breast as established by photographic imaging and ultrasound imaging of the treated area.
Secondary endpoints will provide supportive data to evaluate device performance (subject satisfaction \& fat reduction measured with ultrasound).
Read the detailed description
not desired
- Conditions
- Gynecomastia
- Being tested
- Zeltiq Coolsculpting System
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeltiq Coolsculpting SystemDevice
Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
| Study group | Role | What they receive |
|---|---|---|
| Zeltiq Coolsculpting System | Experimental | non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures. Receives: Device: Zeltiq Coolsculpting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the fat layer
Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast.
Measured: 8 months
Secondary outcomes (1)
visual reduction of the fat layer
Subject satisfaction measured by subject questionnaires.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dermatology, Laser & Vein Specialists of the Carolinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Girish Munavalli, MD MHS, Dermatology, Laser & Vein Specialists of the Carolinas
- Investigators
- Girish S Munavalli, MD MHS, Principal investigator, Dermatology, Laser & Vein Specialists of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791660
- Sponsor's protocol ID
- DLVSC-ZA-001
- Status last verified
- Feb 2013
- First submitted
- 31 Aug 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
- ClinicalTrials.gov ID
- NCT01791660
- Acronym / sponsor ID
- DLVSC-ZA-001
- Conditions
- Gynecomastia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Dermatology, Laser & Vein Specialists of the CarolinasUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 15 Feb 2013 (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.
Protocol is intended for the clinical evaluation of fat reduction in male breasts (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the flanks, and is commercially available.
Primary study endpoint is changes in the shape and reduction of the fat in the breast as established by photographic imaging and ultrasound imaging of the treated area.
Secondary endpoints will provide supportive data to evaluate device performance (subject satisfaction \& fat reduction measured with ultrasound).
Detailed description
not desired
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeltiq Coolsculpting System | Experimental | Device: Zeltiq Coolsculpting Systemnon-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- INCLUDED:
Key exclusion criteria (19 listed)
- <!-- -->
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 |
|---|---|---|
| Zeltiq Coolsculpting SystemNon-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures. | Device | Zeltiq Coolsculpting System |
Primary outcome
reduction of the fat layer
Time frame: 8 months
Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast.
1 secondary outcome
visual reduction of the fat layer
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- related informationLink provided by the sponsor.
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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.
Girish S Munavalli, MD MHS principal investigator
Dermatology, Laser & Vein Specialists of the Carolinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zeltiq Coolsculpting System in people with Gynecomastia, run by Dermatology, Laser & Vein Specialists of the Carolinas at 1 site in United States.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy L Tucker, RN CCRP (704-375-6766 ext. 3537, nurse@carolinaskin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of the fat layer (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2013.