Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 16
- 主要终点
- Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit
研究概览
简要总结
Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.
详细描述
The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit
时间窗: 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
时间窗: 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.
次要结局
- Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)(4-week post-treatment follow-up visit)