NCT01848626已完成不适用
Study With Advanced Vaginal Tactile Imager
Artann Laboratories1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Imaging performance
研究概览
简要总结
The objectives of this study are:
- To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;
- To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines;
- To test the data collection technique and establish a reliable examination procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women (over the age of 21) falling within one of the following groups:
- •No evidence of pelvic floor disorder and no prior pelvic surgery;
- •Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.
排除标准
- •Active skin infection or ulceration within the vagina
- •Presence of a vaginal septum;
- •Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
- •Ongoing radiation therapy for pelvic cancer;
- •Impacted stool;
- •Recent (less than three months) pelvic surgery;
- •Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
- •Severe hemorrhoids;
- •Surgically absent rectum or bladder;
- •Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician.
结局指标
主要结局
Imaging performance
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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