Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01200303 | Evaluation of Computer-assisted, Non-cathartic CT Colonography | PHASE2 | COMPLETED | 605 | — | — | Jun 1, 2005 | Jan 1, 2011 | Aug 5, 2015 | 3 | United States |
this is a prospective test comparison of non-cathartic, CAD-assisted CT Colonography to segmentally unblinded optical colonoscopy (OC), latter serving with pathology specimens as reference standard for presence of polyps.
| Arm | Type | Description |
|---|---|---|
| non-cathartic CTC and OC | ACTIVE_COMPARATOR | This is a single arm, open label, prospective test comparison of non-cathartic, CAD-assisted CTC to segmentally unblinded optical colonoscopy (OC). All study subjects receive both tests, starting with CTC, followed by OC within 5 weeks. CTC results are recorded and revealed to endoscopist on a segment-by-segment basis after initial (blinded) OC evaluation; endoscopist can double check / confirm lesion presence after unblinding and this second read serves as reference standard. |
| Name | Type | Description |
|---|---|---|
| non-cathartic CTC | PROCEDURE | non-cathartic, CAD-assisted CT Colonography |
Inclusion Criteria: * age 50-80, eligible for colon screening Exclusion Criteria: * prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, CT Colonography) within last 5 years * personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer,...