NL-OMON39301尚未招募不适用
Feasibility, Multi-center prospective study of Check-Cap's P1 Capsule System in Patients eligible for CRC screening - Check Cap-P1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male of female between 50 and 75 years of age
- •- Patients which are generally healthy
- •-Patients who are ready to undergo the capsule monitoring procedure and FOBT (or FIT) and the follow up colonoscopy examination
- •- Have a significant clinical finding(s) in prior colon examination with suspected colon polyp: Virtual Colonoscopy or diagnostic colonoscopy. This criteria will apply to a cohort of at least 25 patients out of the total population
- •- Sign informed consent.
排除标准
- •Patients with known GI related symptoms, complains or GI diseases such as:
- •- Crohn's disease
- •-Chronic constipation
- •- Mega colon
- •-Strictures in the GI tract
- •- patients with cancer or other life threatening diseases or conditions
- •Pregnant women (to be verified by test in case of doubt)
- •Patients who underwent any abdominal surgery
- •Patients who underwent any endoscopic examination showing pathology (except polyps)
- •Patients with cardiac pacer or any other implanted or external portable medical device (i.e. infusion pumps)
- •Bed-ridden or sedentary patients
- •Morbid Obesity (BMI > 40)
- •Patients who are unable to undergo the bowel preparation necessary for optical colonoscopy (based on previous attempts or self declaration)
- •Patients who are contraindicated from performing colon cleansing (bowel prep.)
- •Drug abuse or alcoholism
- •Patients under custodial care
- •Participation in current clinical study or clinical study within 30 days prior to the procedure
研究者
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