NL-OMON55511招募中不适用
COlon Capsule Endoscopy as an AlterNative for CT-colonography in Colorectal Cancer Screening - The OCEAN Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
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
- •1. Participation in the Dutch national CRC screening programme
- •2. Positive result on FIT screening
- •3. Contra-indications to undergo colonoscopy or sedation OR
- •4. Not willing to undergo colonoscopy OR
- •5. Prior incomplete colonoscopy
排除标准
- •1. Inability or refusal to provide informed consent
- •2. Persons with a severe or terminal disease with a life-expectancy of less
- •than 5 years
- •3. An allergy or any other known contraindication to the medication used in
- •4. Renal failure, eGFR <30 ml/min/1.73m2
- •5. Congestive heart failure NYHA class III or IV
- •6. Dysphagia or other swallowing disorder which makes it impossible to swallow
- •the capsule
- •7. High risk of capsule retention: IBD, personal history of gastrointestinal
- •surgery other than uncomplicated procedures that would be unlikely to lead to
- •bowel obstruction based on the clinical judgment of the investigator
- •8. Cardiac pacemakers or other implanted electro-medical equipment
- •9. An MRI scheduled within 14 days after ingestion of the capsule
- •10. Patients with diagnosed or suspected Congenital Long QT Syndrome
- •11. Patients with high risk concomitant use of drugs that prolong the QT
- •interval. The risk should be based on the concerning medication in combination
- •with the dosages and should be evaluated based on the clinical judgement of the
- •investigator.
- •12. Patients with manifest hyperthyroidism
- •13. Patients with an allergy or hypersensitivity for iodinated agents
研究者
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