NL-OMON25818招募中不适用

Colon Capsule Endoscopy as an Alternative to CT-colonography in Colorectal Cancer Screening

MLDS grant, Colon capsules and corresponding materials will be provided by Medtronic0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following
•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

•A potential subject who meets any of the following criteria will be excluded from
•participation in this study:
•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 this study
•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
•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 concomitant use of drugs that prolong the QT interval
•12. Patients with insulin dependent diabetes
•13. Patients with manifest hyperthyroidism
•14. Patients with an allergy or hypersensitivity for iodinated agents

发起方

MLDS grant, Colon capsules and corresponding materials will be provided by Medtronic