Bio Colposcopy System CIP: Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 主要终点
- Performance
研究概览
简要总结
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
详细描述
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
The Biop Digital Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the digital colposcope are to be viewed on a color display. The digital colposcope is intended for use in hospitals, clinics, and doctor's offices.
The Biop Micro Colposcope probe unit is an imaging tool intended to be placed in the vagina for acquisition of images of the cervix. It is intended as an adjunct to the Biop Digital Colposcope. It should NOT be used as a substitute for a thorough colposcopic evaluation. The Biop Micro Colposcope Probe unit is not intended for use on the vulva and vagina.
It is anticipated that it will take approximately 3 months to complete active enrollment. Study duration for each subject is 1-2 days, including screening, enrolment and procedure. The study will be completed when the final study subject has completed the procedure.
- Performance - to confirm that average image registration error is less than or equal to (≤) 2mm.
- Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing cervical colposcopy procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, ages 22 to 65 years old
- •Referred for colposcopy, following abnormal cervical cytology
- •Subject provides signed informed consent
排除标准
- •Currently pregnant or nursing
- •Currently menstruating
- •Currently has intrauterine device (IUD)
- •Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera.
- •Diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system
- •HIV-positive status
- •Psychological instability, inappropriate attitude or motivation
- •Use of any additional experimental drug or device or participation in another clinical study within the past 30 days
研究组 & 干预措施
Biop Coplposcopy System
Biop Colposcopy system procedure
干预措施: Biop Colposcopy System (Device)
结局指标
主要结局
Performance
时间窗: procedure day ± 1 day
The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.
frequency and incidence of all Adverse Events
时间窗: procedure day ± 1 day
Safety endpoints include frequency and incidence of all Adverse Events (AE) and Serious Adverse Events (SAE) related and unrelated to the device use.
次要结局
未报告次要终点