NCT03917160已完成不适用
A Randomized Controlled Trial to Evaluate the Effect of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
InMode MD Ltd.4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Post-partum women aged 18-45 years with symptoms of diastasis recti and weakness of the linea alba
- •Informed Consent Form signed by the subject.
- •BMI interval: 18.5 ≤ BMI ≤ 32 (normal to overweight, but not obese).
- •Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
- •Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
- •In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
排除标准
- •- Unable to commit to future appointments
- •Planning on moving away from the local area within 6 months
- •History of other energy-based therapy within one year
- •Diffuse pain syndrome or chronic pain requiring daily narcotics
- •Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator
- •Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other.
- •Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
- •Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- •History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin.
- •Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- •Pregnancy.
- •Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilization.
- •Isotretinoin (Accutane) within last 6 months.
- •Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, open lacerations, abrasions or lesions, infection in the area to be treated, current urinary tract infection or pelvic infection, uterine prolapse, cystocele, rectocele.
- •Any surgical procedure in the treatment area within the last 12 months or before complete healing.
- •Having received treatment with light, laser, RF, or other devices in the treated area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session, as per the practitioner's discretion.
- •As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
- •Any therapies or medications which may interfere with the use of the study device.
- •Compromised health as determined by the study doctor.
结局指标
主要结局
Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
时间窗: 1 month
Up to 5 subjects will undergo MRI to evaluate effect of the treatment
Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment
时间窗: 1 Month, 3 Months, 6 Months
次要结局
- Investigator satisfaction(1 Month, 3 Months, 6 Months)
- Subject improvement and satisfaction(1 Month, 3 Months, 6 Months)
- Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory.(1 Month, 3 Months, 6 Months)
- Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale.(1 Month, 3 Months, 6 Months)
研究者
研究点 (4)
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