Trial Outcomes & Findings for EMS for Abdominal and Gluteal Muscle Toning (NCT NCT03983304)

Last Updated: 2025-05-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

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

Results posted on

2025-05-16

Participant Flow

Participants received EMS therapy on abdomen and/or buttocks in 4 sessions over a 2-week period, with follow-up visits 4 and 12 wks post final treatment. Per-protocol Population included all treated participants followed for 4 wks post treatment, with weight change of no more than 5% of total body weight at the time of the 4-Wk post-treatment images compared to baseline (pre-treatment) images, and who completed 4 treatments. Per protocol, data presented here as planned/collected (all enrolled).

Participant milestones

Participant milestones
Measure	EMS Device Treatment Group All enrolled participants treated with the EMS device.
Overall Study STARTED	110
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	EMS Device Treatment Group All enrolled participants treated with the EMS device.
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	2

Baseline Characteristics

EMS for Abdominal and Gluteal Muscle Toning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMS Device Treatment Group n=110 Participants All enrolled participants treated with the EMS device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Am Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pac Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	88 Participants n=5 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants
Race/Ethnicity, Customized Unknown - Missing Data Point	1 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants
BMI	23.3 kg/m^2 STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	EMS Device Treatment - Abdomen n=92 Participants All eligible participants for whom informed consent is obtained will be treated on the abdomen with the study device, an electromagnetic muscle stimulation device.	EMS Treatment - Buttocks n=32 Participants All eligible participants for whom informed consent is obtained will be treated on the buttocks with the study device, an electromagnetic muscle stimulation device.
Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit	5.1 Participants completed Questionnaire Standard Deviation 5.4	5.5 Participants completed Questionnaire Standard Deviation 5.3

PRIMARY outcome

Timeframe: AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.

Population: All participants enrolled in the study and treated with the EMS device were evaluated for adverse events throughout the study. Investigators determined if an AE was not related, possibly related, probably related or definitely related to the study device. Data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).

The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.

Outcome measures

Outcome measures
Measure	EMS Device Treatment - Abdomen n=110 Participants All eligible participants for whom informed consent is obtained will be treated on the abdomen with the study device, an electromagnetic muscle stimulation device.	EMS Treatment - Buttocks All eligible participants for whom informed consent is obtained will be treated on the buttocks with the study device, an electromagnetic muscle stimulation device.
Number of Incidents of Device-Related Adverse Events	6 Device-Related Adverse Events	—

SECONDARY outcome

Timeframe: 4-week post-treatment follow-up visit

Population: Per-protocol population. Participants with completed questionnaires at the 4-week post treatment follow-up visit.

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".

Outcome measures

Outcome measures
Measure	EMS Device Treatment - Abdomen n=94 Participants All eligible participants for whom informed consent is obtained will be treated on the abdomen with the study device, an electromagnetic muscle stimulation device.	EMS Treatment - Buttocks n=33 Participants All eligible participants for whom informed consent is obtained will be treated on the buttocks with the study device, an electromagnetic muscle stimulation device.
Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)	68.1 percentage of participants Interval 57.7 to 77.3	81.8 percentage of participants Interval 64.5 to 93.0

Adverse Events

EMS Device Treatment Group

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EMS Device Treatment Group n=110 participants at risk 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.
Blood and lymphatic system disorders Lymphoma	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).

Other adverse events

Other adverse events
Measure	EMS Device Treatment Group n=110 participants at risk 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.
Surgical and medical procedures Elective surgery	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Reproductive system and breast disorders Uterine Fibroid	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Pregnancy, puerperium and perinatal conditions Pregnancy	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Coughing	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Cold (virus)	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Musculoskeletal and connective tissue disorders Sprained ankle	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Menstrual Cycle Irregularity	3.6% 4/110 • Number of events 4 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Soreness and discomfort in left chest	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Cramping in lower abdomen	0.91% 1/110 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).

Additional Information

Lori Brandt, Director, Clinical Trial Management

Zeltiq Aesthetics

Phone: 925 621-7460

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place