Clinical trial NCT03983304: EMS for Abdominal and Gluteal Muscle Toning
Official title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Therapeutic Body Modification
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2019-06-12
Enrollment: 110
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

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

Eligibility 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.

Primary outcomes:
measure: Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit
timeFrame: Baseline, 4-week post-treatment follow-up visit
measure: Number of Incidents of Device-Related Adverse Events
timeFrame: AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.
Secondary outcomes:
measure: Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)
timeFrame: 4-week post-treatment follow-up visit
Other outcomes:
Locations:
city: Marina Del Rey
country: United States
facility: Marina Plastic Surgery
state: California
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
city: Miami
country: United States
facility: Bowes Dermatology by Riverchase
state: Florida
city: Shreveport
country: United States
facility: The Wall Center for Plastic Surgery
state: Louisiana
city: Chevy Chase
country: United States
facility: Capital Laser & Skin Care
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians of Chestnut Hill
state: Massachusetts
city: Dallas
country: United States
facility: EpiCentre Park Lane
state: Texas
Study officials:
affiliation: Zeltiq Aesthetics
name: Kerrie Jiang, NP
role: STUDY_DIRECTOR
References:
citation: Fabi S, Dover JS, Tanzi E, Bowes LE, Tsai Fu F, Odusan A. A 12-Week, Prospective, Non-Comparative, Non-Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks. Lasers Surg Med. 2021 Jan;53(1):79-88. doi: 10.1002/lsm.23348. Epub 2020 Nov 8.