EMS for Abdominal and Gluteal Muscle Toning

Study Overview
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Brief Summary
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Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Official Title
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Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning

Conditions
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Muscle Weakness

Intervention / Treatment
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* Device: The ZELTIQ System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle Toning<br>The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks. | Device: The ZELTIQ System<br>* The EMS device will be used to perform the treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |