Non-Therapeutic Body Modification
Conditions
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.
Interventions
DEVICEThe ZELTIQ EMS System
The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit | Baseline, 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. |
| Number of Incidents of Device-Related Adverse Events | AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment. | The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| EMS Device Treatment Group All enrolled participants treated with the EMS device. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | EMS Device Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| BMI | 23.3 kg/m^2 STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized Am Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pac Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 8 Participants |
| Race/Ethnicity, Customized Unknown - Missing Data Point | 1 Participants |
| Race/Ethnicity, Customized White | 88 Participants |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 11 / 110 |
| serious Total, serious adverse events | 1 / 110 |
Outcome results
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.
Time frame: Baseline, 4-week post-treatment follow-up visit
Population: Per-protocol population. Participants with completed questionnaires specific to each body area treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMS Device Treatment - Abdomen | Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit | 5.1 Participants completed Questionnaire | Standard Deviation 5.4 |
| EMS Treatment - Buttocks | Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit | 5.5 Participants completed Questionnaire | Standard Deviation 5.3 |
Primary
Number of Incidents of Device-Related Adverse Events
The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMS Device Treatment - Abdomen | Number of Incidents of Device-Related Adverse Events | 6 Device-Related Adverse Events |
Secondary
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.
Time frame: 4-week post-treatment follow-up visit
Population: Per-protocol population. Participants with completed questionnaires at the 4-week post treatment follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMS Device Treatment - Abdomen | Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS) | 68.1 percentage of participants |
| EMS Treatment - Buttocks | Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS) | 81.8 percentage of participants |