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Procedure

Zeltiq Coolsculpting System for Gynecomastia

N/A
Waitlist Available
Led By Girish S Munavalli, MD MHS
Research Sponsored by Dermatology, Laser & Vein Specialists of the Carolinas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
reduction of the fat layer
Secondary outcome measures
visual reduction of the fat layer

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zeltiq Coolsculpting SystemExperimental Treatment1 Intervention
non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

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Who is running the clinical trial?

Dermatology, Laser & Vein Specialists of the CarolinasLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Girish S Munavalli, MD MHSPrincipal InvestigatorDermatology, Laser & Vein Specialists of the Carolinas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System
Girish Munavalli, MD MHS 2012. "Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01791660.
All > Gynecomastia
~1 spots leftby Apr 2025
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