Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

Wuerzburg University Hospital

Status: Completed

Conditions: Artificial Intelligence; Surveillance Endoscopy for Colorectal Cancer; Polyps of Colon; CADe

Treatments: Device: ENDOMIND

Study type: Interventional

Funder types: Other

Identifiers

NCT05006092

F-2021-047

Details and patient eligibility

About

Evaluation of an artificial intelligence system for polyp detection (CADe)

Full 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.

Enrollment: 1,149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,149 participants in 2 patient groups

surveillance endoscopy with CADe support

Experimental group

Description:

Endoscopy perfomed with CADe support.

Treatment:

Device: ENDOMIND

conventional surveillance endoscopy

No Intervention group

Description:

Endoscopy perfomed without CADe support.