Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Surveillance Endoscopy for Colorectal Cancer Artificial Intelligence Polyps of Colon CADe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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surveillance endoscopy with CADe support

Endoscopy perfomed with CADe support.

Group Type EXPERIMENTAL

ENDOMIND

Intervention Type DEVICE

CADe system for Polyp detection

conventional surveillance endoscopy

Endoscopy perfomed without CADe support.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ENDOMIND

CADe system for Polyp detection

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes