colorectal adenomas Colorectal polyps
Conditions
Interventions
None listed
Sponsors
GIVEN IMAGING LIMITED
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients referred to colonoscopy for at least one of the following reasons: - Colorectal cancer screening for age *50 - Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits for age *50 - Positive findings in the left colon during sigmoidoscopy(e.g. Polyp *10mm) - Personal history of polyps that were removed at least 3 years ago
Exclusion criteria
Exclusion criteria: 1. 80 Years 2. Subject has dysphagia or any swallowing disorder 3. Subject has congestive heart failure 4. Subject has high risk of renal insufficiency associated with the use of sodium phosphate 5. Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator 6. Subject has any allergy or other known contraindication to the medications used in the study 7. Surgical intestinal anastomosis 8. Subject has a cardiac pacemaker or other implanted electro medical device. 9. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. 10. Known or suspected gastro-intestinal obstruction 11. Subject has known delayed gastric emptying 12. Women who are either pregnant at the time of screening, or are of childbearing potential and do not practice medically acceptable methods of contraception. 13. Subject currently participating in another clinical study 14. No informed consent, or inability to understand patient information and/ or give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy parameters of PillCam* COLON 2 in detecting patients with colonic polyps *6mm and *10 mm as compared to conventional colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Diagnostic yield of PillCam* COLON 2 in detecting colonic lesions as compared to conventional colonoscopy 2) Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy 3) Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos 4) Capsule transit time within stomach, small bowel and colon based on Rapid videos 5) Prevalence of polyps at different size categories and locations as detected by capsule 6) Prevalence of polyps at different size categories and locations as detected by conventional colonoscopy 7) RAPID reading time 8) Number, type and severity of adverse events | — |
Countries
Netherlands
Outcome results
None listed