NCT01111916已完成不适用
A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue
Artann Laboratories2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年3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
- 31
- 试验地点
- 2
- 主要终点
- To determine whether there is a detectable difference in 3-D elasticity images provided by Vaginal Tactile Imager for the patients with presence or absence of prolapse.
研究概览
简要总结
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.
详细描述
Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable examination procedure, collect data necessary for assessing the performance of Vaginal Tactile Imaging sensors, assess clinical suitability of interface software and correlate elasticity measurements with clinical examination findings for normal versus prolapse conditions of the female pelvis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •no evidence of pelvic organ prolapse and no prior pelvic surgery
- •stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments
- •no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material)
排除标准
- •patients with active skin infection, tissue breakdown or ulceration
- •patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion
- •recent pelvic surgery with less than 3-month interval from surgery
结局指标
主要结局
To determine whether there is a detectable difference in 3-D elasticity images provided by Vaginal Tactile Imager for the patients with presence or absence of prolapse.
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (2)
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