A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Number of Unanticipated Adverse Device Effects (UADE)
研究概览
简要总结
Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
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 and female subjects > 22 years of age and ≤65 years of age.
- •Subject has not had weight change exceeding 5% of body weight in the preceding month.
- •Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
- •Subject agrees to refrain from any new abdominal training exercises during the course of the study.
- •BMI ≤ 30 kg/m^2 as determined at screening.
- •Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus.
- •Cohort 4 only: Subject participated in protocol ZA18-003 in Cohort 3, and received the CoolSculpting treatment no more than 6 months prior.
- •Subject has read and signed a written informed consent form.
排除标准
- •Subject has had a surgical procedure(s) in the area of intended treatment.
- •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, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months.
- •Subject has numbness, tingling or other altered sensation in the treatment area.
- •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 known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria
- •Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- •Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising.
- •Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol, or latex.
- •Subject is taking or has taken diet pills or supplements within the past month.
- •Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites, that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- •Subject has a metal implant or active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- •Subject has been involved in any type of abdominal muscle training program within the previous 6 months.
- •Subject has pulmonary insufficiency.
- •Subject has a cardiac disorder.
- •Subject has a malignant tumor.
- •Subject has been diagnosed with epilepsy.
- •Subject currently has a fever.
- •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
Number of Unanticipated Adverse Device Effects (UADE)
时间窗: Enrollment through the final 12-week follow-up visit.
The number of UADEs occurring during the study will be tabulated.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
时间窗: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.
Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
次要结局
- Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement(Final post-treatment 12-week follow-up visit)
- Change in Pre-treatment and Post-treatment Abdominal Circumference(Baseline and final 12-week follow-up visit.)