NCT06460818已完成不适用
Surgical Sample Collection- Sampling During Uterine Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PinkDx, Inc.
- 入组人数
- 234
- 试验地点
- 3
- 主要终点
- Number of participants with optimal vaginal samples obtained during the collection process
研究概览
简要总结
The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.
- •Willing and able to comply with scheduled visits, investigational plan, and other procedures.
- •Aged >45 for benign and pre-malignant cases
- •Aged >18 with positive biopsies.
- •Presence of uterus.
- •Scheduled for hysterectomy.
排除标准
- •Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
- •Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
- •Women who have undergone a hysterectomy.
- •Inability or unwillingness to sign informed consent.
- •Contraindication to surgery, including pregnancy.
- •Women who have used a tampon within 7 days of surgery.
结局指标
主要结局
Number of participants with optimal vaginal samples obtained during the collection process
时间窗: 9 months
Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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