Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE) (SMARTIE)

April 26, 2023 updated by: Wuerzburg University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Würzburg, Bayern, Germany, 97080
        • Universitatsklinikum Wurzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: surveillance endoscopy with CADe support
Endoscopy perfomed with CADe support.
Device: ENDOMIND
CADe system for Polyp detection
No Intervention: conventional surveillance endoscopy
Endoscopy perfomed without CADe support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adenoma detection rate
Time Frame: 4 months
proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polyp detection rate
Time Frame: 4 months
Exmainations with minimum one polyp detected.
4 months
withdrawal time
Time Frame: 4 months
Time of withdrawal.
4 months
resection time
Time Frame: 4 months
Time spent on polyp resections.
4 months
Boston Bowl Preparation Score
Time Frame: 4 months
minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

Klinikum Stuttgart

Investigators

  • Principal Investigator: Alexander Hann, Wuerzburg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2021-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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