EMS for Abdominal and Gluteal Muscle Toning (CTP)

Zeltiq Aesthetics

Status

Completed

Conditions

Non-Therapeutic Body Modification

Treatments

Device: The ZELTIQ EMS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03983304

ZA19-002

Details and patient eligibility

About

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Full description

The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.

Enrollment

110 patients

Sex

All

Ages

22 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.