Clinical trial · Interventional
Computer Aided Detection of Polyps in Colonoscopy
Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
- 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 aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer Aided Detection device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Routine Colonoscopy
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Routine Colonoscopy with the use of Skout
- interventionNames
- Device: Computer Aided Detection device
Primary outcomes (2)
- measure
- Adenomas per colonoscopy
- timeFrame
- At the end of the procedure, 1 day
- description
- The total number of adenomas detected divided by the total number of colonoscopies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria Participants will be eligible for this study if they are: * Undergoing colonoscopy with screening, surveillance, or diagnostic indications. * Undergoing a procedure by a participating endoscopist. * Have given informed consent. Exclusion Criteria Participants will not be eligible for this study if they: * Have a history of inflammatory bowel disease. * Have a history of familial adenomatous polyposis. * Are under the age of 40. * Have had a colonoscopy within the previous three (3) years. * Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test. * Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator). * Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.
References
Publications (1)
- DERIVEDShaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT Registration Study Team. Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25. PMID 35643173