Muscle Weakness
Conditions
Brief summary
Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.
Interventions
DEVICEMagnetic Muscle Stimulation (MMS) device
The MMS device will be used to perform the treatments.
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 have MRI during the scheduled time periods. * Subject agrees to refrain from any new abdominal 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 has had a non-invasive fat reduction procedure (e.g. CoolSculpting, SculpSure) in the area of intended treatment within the past 6 months. * 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 had an intrauterine contraceptive device inserted or removed within the past month. * Subject has a bleeding disorder or hemorrhagic condition * Subject is taking or has taken diet pills or supplements within the past month. * Subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system * Subject has metal or electronic implants in or adjacent to the treatment area * Subject has an abdominal hernia * 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 has a growth plate in the treatment area * 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 has any contraindications to MRI (e.g. metal implant, history of metal work or metal slivers in eye, prone to severe claustrophobia). * Subject is unable or unwilling to comply with the study requirements. * Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * 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 1-Month Post-Treatment Follow-up Visit | Baseline, 1-month post-treatment follow-up visit | Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month 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). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score. |
| Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment. | An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE. |
Countries
United States
Participant flow
Pre-assignment details
Participants were assigned to 1 of 3 MMS treatment cohorts. As-Treated (Safety) Population includes all enrolled participants who received at least 1 treatment per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period. | 19 |
| Cohort 2 Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. | 6 |
| Cohort 3 Participants had 8 MMS treatments completed twice per week within a 4-week period. | 5 |
| Total | 30 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 11.3 | 43.5 years STANDARD_DEVIATION 13.5 | 44.2 years STANDARD_DEVIATION 14.2 | 45.2 years STANDARD_DEVIATION 11.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 15 Participants | 5 Participants | 4 Participants | 24 Participants |
| Sex: Female, Male Female | 18 Participants | 4 Participants | 3 Participants | 25 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 1 / 19 | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 19 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month 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). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Time frame: Baseline, 1-month post-treatment follow-up visit
Population: As-Treated Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit | 6.2 units on a scale | Standard Deviation 4.9 |
| Cohort 2 | Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit | 4.7 units on a scale | Standard Deviation 6.1 |
| Cohort 3 | Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit | 2.8 units on a scale | Standard Deviation 4.1 |
Primary
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
Time frame: AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment.
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | Device and/ or Procedure Related AEs | 1 Participants |
| Cohort 1 | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | SADEs | 0 Participants |
| Cohort 2 | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | Device and/ or Procedure Related AEs | 0 Participants |
| Cohort 2 | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | SADEs | 0 Participants |
| Cohort 3 | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | Device and/ or Procedure Related AEs | 0 Participants |
| Cohort 3 | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | SADEs | 0 Participants |