UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Intrauterine pathology detection rate with Visual Saline Infusion
研究概览
简要总结
This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.
详细描述
This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.
Patients who are enrolled in the study will have a 1) Hydrosonography, and 2) Visual Saline Infusion procedure performed.
The Visual Saline Infusion Device is a 2.7mm, steerable tip catheter with a camera and illumination at the distal end. The device is intended to evaluate the intrauterine space in an office based, outpatient setting using minimal volume of fluid (3-5cc's).
This study will recruit up to 100 women from a fertility center in Los Angeles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients requiring a uterine cavity evaluation
- •Premenopausal women between ages of 18-45
排除标准
- •1. Positive test or history of any of the following conditions:
- •1a. Chlamydial pelvic infection
- •1b. Gonorrheal pelvic infection.
- •Positive Pregnancy Test
- •IUD currently in place
结局指标
主要结局
Intrauterine pathology detection rate with Visual Saline Infusion
时间窗: Procedure of approximately 2-5 minute duration
The assessment will involve the examination of the intrauterine cavity for the presence of known pathologies, including polyps, fibroids, adhesions, scar tissue, thickened endometrium, among others. The detection rate will be calculated as the ratio of the number of cases where abnormal pathologies are identified to the total number of cases examined.
Intrauterine pathology detection rate with Hydrosonography
时间窗: Procedure of 2-5 minute duration
The assessment will involve the examination of the intrauterine cavity for the presence of pathologies, including polyps, fibroids, adhesions, scar tissue, thickened endometrium, among others. The detection rate will be calculated as the ratio of the number of cases where abnormal pathologies are identified to the total number of cases examined.
次要结局
- Visual detection quality score (1-10)(Captured during procedure)
- Pain during procedure(Collected on day of procedure)
- Fluid used during distention(Captured during procedure)
- Adverse events rate(Day of procedure and 24-48 hours post to procedure)