Magnetic Muscle Stimulation of Abdominal Muscle
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit
研究概览
简要总结
Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.
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 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.
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 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.
结局指标
主要结局
Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点