NCT01491334已完成不适用
A Clinical Validation Study With Transvaginal Tactile Imaging
Artann Laboratories2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2011年12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
- 158
- 试验地点
- 2
- 主要终点
- Effectiveness in assessment of the pelvic floor tissue conditions.
研究概览
简要总结
The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.
详细描述
- The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.
- The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.
- The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.
- The device will detect significant differences in tissue elasticity among 3 control groups with normal pelvic floor conditions (nulliparous women at age 21-30, parous women at age 31-40, and postmenopausal women).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING
- •No evidence of pelvic organ prolapse and no prior pelvic surgery
- •Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery
- •Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled
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
Effectiveness in assessment of the pelvic floor tissue conditions.
时间窗: Two years.
Ability in early detection of prolapse conditions.
时间窗: One Year
Ability in characterization of the outcome of pelvic floor reconstructive surgery.
时间窗: Two years.
次要结局
未报告次要终点
研究者
研究点 (2)
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