Colon Cancer Screening, Colon Cancer Surveillance
Conditions
Keywords
Colon cancer screening, Colon cancer surveillance, Computer-Aided Detection of adenoma, Colonoscope attachment device, Endocuff
Brief summary
Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.
Interventions
DEVICEEndocuff and GI Genius
Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
DEVICEGI Genius
GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
Sponsors
Marshall University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 * Patients scheduled for an outpatient screening or surveillance colonoscopy.
Exclusion criteria
* Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding). * Patients requiring deep ileal intubation. * Patients with inflammatory bowel disease. * Patients with radiotherapy-induced colitis or other severe colitis. * Patients with colonic strictures. * Patients with acute diverticulitis. * Patients with large bowel obstruction. * Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps). * Patients scheduled for assessment of a known colonic lesion. * Patients with a known history of hereditary polyposis syndrome or untreated colon cancer. * Patients with a history of colon resection. * Patients on continuous anti-thrombotic therapy * Pregnancy. * Patients who are ineligible for colonoscopy due to medical or psychiatric conditions. * Patients who are vulnerable or unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 18 months | It is the percentage of patients who have at least one adenoma detected during the colonoscopy |
Secondary
| Measure | Time frame |
|---|---|
| Number of cancerous lesions | 18 months |
| Differences in polyps histology between the groups | 18 months |
| Differences in polyps size | 18 months |
| Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum) | 18 months |
| Polyp detection rate | 18 months |
| Cecal intubation time | 18 months |
| Colonoscopy withdrawal time | 18 months |
| Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods) | 18 months |
| Cecal intubation rate | 18 months |
Countries
United States
Outcome results
None listed