NCT01791660

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

August 31, 2012

Last Update Submit

February 12, 2013

Conditions

Gynecomastia

Outcome Measures

Primary Outcomes (1)

  • reduction of the fat layer

    Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast.

    8 months

Secondary Outcomes (1)

  • visual reduction of the fat layer

    8 months

Study Arms (1)

Zeltiq Coolsculpting System

EXPERIMENTAL

non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Device: Zeltiq Coolsculpting System

Interventions

Zeltiq Coolsculpting SystemDEVICE

Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Zeltiq Coolsculpting System

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • EXCLUDED:
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  • 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Girish S Munavalli, MD MHS

    Dermatology, Laser & Vein Specialists of the Carolinas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy L Tucker, RN CCRP

CONTACT

704-375-6766nurse@carolinaskin.com

Razia Ludin, Research assistant

CONTACT

704-375-6766razial@carolinaskin.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,MHS

Study Record Dates

First Submitted

August 31, 2012

First Posted

February 15, 2013

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(1)