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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03983304
Other study ID # ZA19-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2019
Est. completion date May 1, 2020

Study information

Verified date September 2021
Source Zeltiq Aesthetics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 65 Years
Eligibility Inclusion Criteria - Male or female = 22 years and =65 years of age. - Subject has not had weight change exceeding 5% of body weight in the preceding month. - Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine. - Subject has a BMI = 30 as determined at screening. - Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods. - Subject agrees to refrain from any new abdominal and/or gluteal muscle training exercises of the treatment area during the course of the study. - Subject agrees to avoid sun tanning during the course of the study. - Subject has read and signed the study written informed consent form. Exclusion Criteria - Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process. - Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) 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 not had an intrauterine contraceptive device inserted or removed within the past month. - Subject has a bleeding disorder - Subject is taking or has taken diet pills or supplements within the past month. - Subject has a metal implant or active implanted device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system. - Subject agrees not to change muscle exercise routine in the treatment area (abdominal and/or gluteal) while participating in the study - Subject has pulmonary insufficiency. - Subject has a cardiac disorder. - Subject has a malignant tumor. - Subject has been diagnosed with a seizure disorder such as epilepsy. - Subject currently has a fever. - Subject is diagnosed with Grave's disease. - Subject is pregnant or intending to become pregnant during the study period (in the next 9 months). - Subject is lactating or has been lactating in the past 6 months. - Subject is unable or unwilling to comply with the study requirements. - Subject is currently enrolled in a clinical study of any other investigational drug or device. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The ZELTIQ System
The EMS device will be used to perform the treatments.

Locations

Country Name City State
United States SkinCare Physicians of Chestnut Hill Chestnut Hill Massachusetts
United States Capital Laser & Skin Care Chevy Chase Maryland
United States EpiCentre Park Lane Dallas Texas
United States Marina Plastic Surgery Marina Del Rey California
United States Bowes Dermatology by Riverchase Miami Florida
United States Innovation Research Center Pleasanton California
United States Cosmetic Laser Dermatology San Diego California
United States The Wall Center for Plastic Surgery Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy Endpoint: Subject Satisfaction Questionnaire Measurement of subject feeling about body shape, assessed using the Body Satisfaction Scale at the 4-Week follow-up visit. 4-wk follow up visit
Secondary Subject Global Aesthetic Improvement Scale (GAIS) Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. 4-wk follow up visit
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