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Completed

NCT Number: NCT05006092

Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

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

Completed

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Key information

Conditions

Surveillance Endoscopy for Colorectal Cancer Artificial Intelligence CADe Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Polyps of Colon

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENDOMIND

Device

CADe system for Polyp detection

Primary outcomes

  1. adenoma detection rate

    Time frame: 4 months

    proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas

Secondary outcomes

  1. polyp detection rate

    Time frame: 4 months

    Exmainations with minimum one polyp detected.

  2. withdrawal time

    Time frame: 4 months

    Time of withdrawal.

  3. resection time

    Time frame: 4 months

    Time spent on polyp resections.

  4. Boston Bowl Preparation Score

    Time frame: 4 months

    minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Klinikum Stuttgart

Registry information

Official study title

Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort

Acronym: SMARTIE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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