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Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System

NCT01791660 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-02-15

No results posted yet for this study

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).

Conditions

  • Gynecomastia

Interventions

DEVICE

Zeltiq Coolsculpting System

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

Sponsors & Collaborators

  • Dermatology, Laser & Vein Specialists of the Carolinas

    lead OTHER

Principal Investigators

  • Girish S Munavalli, MD MHS · Dermatology, Laser & Vein Specialists of the Carolinas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791660 on ClinicalTrials.gov