Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
Not Applicable
Completed
- Conditions
- CADeArtificial IntelligencePolyps of ColonSurveillance Endoscopy for Colorectal Cancer
- Interventions
- Device: ENDOMIND
- Registration Number
- NCT05006092
- Lead Sponsor
- Wuerzburg University Hospital
- Brief Summary
Evaluation of an artificial intelligence system for polyp detection (CADe)
- Detailed Description
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1149
Inclusion Criteria
- indication CRC surveillance endoscopy
- indication post-polypectomy surveillance endoscopy
- positive fecal immunochemical test in patients >=50 years
Exclusion Criteria
- reasonable suspicion of inflammatory bowl disease
- reasonable suspicion of familiar polyposis Syndrome
- Patient after radiation/resection of colonic parts
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surveillance endoscopy with CADe support ENDOMIND Endoscopy perfomed with CADe support.
- Primary Outcome Measures
Name Time Method adenoma detection rate 4 months proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
- Secondary Outcome Measures
Name Time Method withdrawal time 4 months Time of withdrawal.
resection time 4 months Time spent on polyp resections.
polyp detection rate 4 months Exmainations with minimum one polyp detected.
Boston Bowl Preparation Score 4 months minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance
Trial Locations
- Locations (1)
Universitätsklinikum Würzburg
🇩🇪Würzburg, Bayern, Germany