Colon Capsule Endoscopy as an Alternative to CT-colonography in Colorectal Cancer Screening
- Conditions
- This study focuses on colorectal cancer screening (including the diagnostic yield for polyps and colorectal cancer).
- Registration Number
- NL-OMON25818
- Lead Sponsor
- MLDS grant, Colon capsules and corresponding materials will be provided by Medtronic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
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
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method