Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 8
- 主要终点
- Number of successful US-guided breast biopsy
研究概览
简要总结
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 and older female.
- •Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.
排除标准
- •Participants unwilling to sign consent.
- •Participants under the age of 18.
结局指标
主要结局
Number of successful US-guided breast biopsy
时间窗: 1 year
Trainees will be evaluated using a passing criterion of 80% on a validated test that assesses competency based on the The Ottawa Surgical Competency Operating Room Evaluation (O-Score). There are 8 variables rated on a scale of 1-5. A trainee will be given a passing grade if the responses on all 8 variables are 4 or 5 and this is achieved in at least 80% of the unsupervised simulation and patient biopsies.
次要结局
未报告次要终点