Clinical trial · Interventional
Computer Aided Detection of Polyps During Colonoscopy Procedures
NCT04195646CI-TRIAL-00053645completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoVigilant CAD Software | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EndoVigilant CAD Software assisted Colonoscopy Procedure
- description
- The gastroenterologist performing the colonoscopy procedure will be able to observe a standard colonoscopy video on the primary monitor and video augmented by EndoVigilant CAD software on the second monitor. The gastroenterologist will primarily rely on the second monitor but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.
- interventionNames
- Device: EndoVigilant CAD Software
Primary outcomes (1)
- measure
- Adenomas Per Colonoscopy
- timeFrame
- 1 hour
- description
- Averaged Adenomas Per Colonoscopy (APC), to determine if the use of CAD software identifies more adenomas per colonoscopy. This will be generated for the entire study as well as each investigator. This prospectively collected data will be compared against APC for same number of past procedures performed without use of EndoVigilant CAD system, both at aggregate and physician level.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patient presenting for routine colonoscopy for screening and/or surveillance purposes * Ability to provide written, informed consent and understand the responsibilities of study participation Exclusion Criteria: * Patients with diminished cognitive capacity * Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis * Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)
References
Publications (0)
Data not yet available
No reference posted for this study.