Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- safety - transit time (less than 300 hours)
研究概览
简要总结
Prospective, Single arm, Multi-Center
- To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test)
- To collect data about the overall imaging of the colon internal surface during the passage of the capsule
- To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography [CTC] (in patients which were referred after positive CTC examination)
详细描述
Study Title:
Outside USA [OUS] Pilot Multi-center prospective feasibility study
Objectives:
Primary:
To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test) or FIT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 40 and 75 years of age.
- •Subject is generally in good health.
- •Subject is ready to undergo FOBT or FIT and Colonoscopy.
- •Subject agrees to sign the informed consent.
排除标准
- •Subject has any known Gastro Intestinal [GI] related symptoms, complaints or GI diseases.
- •Subject is contraindicated from performing colon cleansing (bowel prep.)
- •Subject has cancer or other life threatening diseases or conditions.
- •Female subject is pregnant.
- •Subject underwent any abdominal surgery.
- •Morbid Obese (BMI > 40) subject.
- •Subject has known drug abuse or alcoholism problem.
- •Subject is under custodial care.
- •Subject is currently or will be participating in other clinical study within 30 days prior to Check-Cap procedure
研究组 & 干预措施
P1 capsule and screening Cscopy
Male and female patients older than 40 and younger than 75 years old who volunteer for the experiment and qualify with the inclusion / Exclusion criteria.
The P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study
干预措施: The P1 Check-Cap capsule (Device)
结局指标
主要结局
safety - transit time (less than 300 hours)
时间窗: after each subject (once the capsule in excreted, typically 30-80 hours)
To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters. The measured effect is the correlation of the capsule transit time (hours) with the number of polyps and their size (in mm).
次要结局
- Colon Capsule correlation map (Empirical, qualitative)(end of study (anticipted within 12 months))