EMS for Abdominal and Gluteal Muscle Toning | NCT03983304

NCT03983304

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electromagnetic Muscle Stimulation Treatment Group - Abdomen	Experimental	The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.	Device: The ZELTIQ EMS System
Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks	Experimental	The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.	Device: The ZELTIQ EMS System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The ZELTIQ EMS System	Device	The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.	Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit	Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.	Baseline, 4-week post-treatment follow-up visit
Number of Incidents of Device-Related Adverse Events	The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.	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	Description	Time Frame
Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)	Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. In this study, subjects completed the SGAIS questionnaire for each treated area (e.g. a abdomen-specific questionnaire and a buttocks-specific questionnaire) at the 4-week post-final follow-up visit. Subjects were asked to rate improvement in treated areas using the following 7 point scale: 3 = Very much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -2 = Much worse and -3 = Very much worse. Subjects who reported 'Very Much Improved,' 'Much Improved,' and 'Improved will be categorized as 'Improved'. Results were calculated as the percentage of subjects reporting "Improved".

Eligibility Module

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.

Name	Affiliation	Role
Kerrie Jiang, NP	Zeltiq Aesthetics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Marina Plastic Surgery		Marina del Rey	California	90292	United States
Innovation Research Center

PubMed Identifier	Type	Citation	Retractions
33161584	Result	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.

ID	Title	Description
FG000	EMS Device Treatment Group	All enrolled participants treated with the EMS device.

Baseline Characteristics Module

ID	Title	Description
BG000	EMS Device Treatment Group	All enrolled participants treated with the EMS device.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit

Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.

Per-protocol population. Participants with completed questionnaires specific to each body area treated.

Posted

Mean

Standard Deviation

Participants completed Questionnaire

Baseline, 4-week post-treatment follow-up visit

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EMS Device Treatment Group	All eligible subjects for whom informed consent is obtained were treated with the study device, an electromagnetic muscle stimulation device. Adverse event information was collected from the time of enrollment through the 12-week post-treatment follow-up visit. Per protocol 110 subjects were enrolled to have EMS treatments on the abdomen and/or buttocks in this single arm study. At no point in the conduct of the study were subjects assigned to a treatment group; the investigator determined the area(s) to be treated.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Lymphoma	Blood and lymphatic system disorders		Non-systematic Assessment	Subject reported pain in the abdomen and other symptoms. Investigator referred subject to primary care physician. Subject diagnosed with lymphoma 18 days after treatment. Investigator determined the event as "not related to the study device.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Elective surgery	Surgical and medical procedures		Non-systematic Assessment	Subject reported elective salivary gland surgery.