NCT02974842已完成不适用
Cytological Evaluation of Specimens Collected With the MAKO 7 Device in Pre Salpingo-Oophorectomy Subjects for Determination and/or Differentiation of Normal Versus Atypical Versus Malignant Cells
nVision Medical2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.
研究概览
简要总结
This study evaluates the ability of the MAKO 7 device to collect various cells
详细描述
Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to collect cells from the fallopian tubes for cytological evaluation for determination and/or differentiation of normal versus atypical versus malignant cells.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is medically cleared for surgery
- •Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
- •Subject must be 18 years of age
- •Subject must be able to provide informed consent
排除标准
- •Contraindication to hysteroscopy
- •Acute pelvic inflammatory disease
- •Active or recent lower pelvic infection
- •Delivery or termination of a pregnancy in the past 6 weeks
- •Known tubal obstruction including tubal ligation
- •Invasive carcinoma of the cervix or endometrium
- •Intolerance of anesthesia
结局指标
主要结局
Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.
时间窗: Up to 60 days post-operatively
Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.
次要结局
未报告次要终点
研究者
研究点 (2)
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