User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Using a sonographic/real time ultrasound imaging machine detect if a contraction is stimulated by the 5 minute treatment with the modified Neurotech Device and 5 minute treatment with the Neurotech Vital Device.
研究概览
简要总结
This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device.
详细描述
This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device. Stimulation of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess contractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet the following inclusion criteria will be included in the study.
- •Subjects who are female and at least 18 years of age.
- •Subjects who, in the opinion of the Investigator, are deemed healthy.
- •Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
- •Subjects who are able to understand this study and are willing to complete all the study assessments.
排除标准
- •Subjects who meet any of the following criteria will be excluded from participation in the study.
- •Subjects who have an existing medical condition that would compromise their participation in the study.
- •Subjects who have a physical condition that would make them unable to perform the study procedures.
- •Subjects with a history of any respiratory condition including a chronic cough.
- •Subjects with a history of an underlying neurological condition.
- •Subjects with a history of low back pain involving the spinal nerve root.
- •Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
- •Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
- •Subjects with a clinical diagnosis of prolapse greater than Stage
- •Subjects who are pregnant or could be pregnant.
- •Subjects who are less than 6 months post-partum or who are lactating.
- •Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
- •Subjects with pelvic pain or fibromyalgia or paravaginal defect.
- •Subjects with an active implanted medical device (ie pacemaker, pump etc).
- •Subjects with a history of heart disease or stroke.
- •Subjects with a known cancer.
- •Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
- •Subjects who are currently involved in any injury litigation claims.
- •Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
- •Subjects who have participated in a clinical study in the last 3 months.
结局指标
主要结局
Using a sonographic/real time ultrasound imaging machine detect if a contraction is stimulated by the 5 minute treatment with the modified Neurotech Device and 5 minute treatment with the Neurotech Vital Device.
时间窗: 5 minutes treatment with each device to measure if contraction occurrs on the ultrasound
The primary endpoint of the study is to demonstrate that no volunteers elicit a contraction of the pelvic floor muscle with the Modified Neurotech Vital Device and that all the volunteers elicit a contraction of the pelvic floor muscle with the Neurotech Vital Device. Contraction of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording (mean of three measurements of pelvic floor displacement achieved during maximum threshold intensity electrical stimulation).
次要结局
- Healthy Volunteers feedback questionnaires(after 5 minutes of treatment)