Artificial Intelligence in Colonic Polyp Detection

June 27, 2023 updated by: Per Hedenström, Sahlgrenska University Hospital, Sweden
A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

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

  • Sweden
      • Gothenburg, Sweden, S-413 45
        • Dr Per Hedenström

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

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients without IBD referred for colonoscopy

Exclusion Criteria:

  • Age < 40 years
  • Not willing to participate

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: AI
Colonoscopy with AI
Device: Artificial intelligence
Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps
Placebo Comparator: No AI
Colonoscopy without AI
Device: No Artificial Intelligence
Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADR
Time Frame: 1 hour
Adenoma detection rate
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
APC
Time Frame: 1 hour
Adenomas per colonoscopy
1 hour
Procedural time
Time Frame: 1 hour
The number of minutes required to complete the colonoscopy withdrawal
1 hour

Collaborators and Investigators

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

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Study Director: Björn Lindkvist, Sahlgrenska University Hospital, Sweden

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 30, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2020-01951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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