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OpenTrials
Completed

NCT Number: NCT04335318

Real Life AI in Polyp Detection

The objective of this study is to compare the polyp detection rate (PDR) of endoscopists unaware of a commercially available artificial intelligence (AI) device for polyp detection during colonoscopy and the PDR of endoscopists with the aid of such a device. Moreover, an extensive characterization of the performance of this device will be done.

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Key information

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

Recently, there have been remarkable breakthroughs in the introduction of deep learning techniques, especially convolutional neural networks (CNNs), in assisting clinical diagnosis in different medical fields. One of these artificial intelligence (AI) devices to diagnose colon polyps during colonoscopy was launched in October 2019. Its intended use is to work as an adjunct to the endoscopist during a colonoscopy with the purpose of highlighting regions with visual characteristics consistent with different types of mucosal abnormalities.

It is essential to know whether deep learning algorithms can really help endoscopists during colonoscopies. Several studies have already addressed this issue with different approaches and results. However, one common drawback of these type of Machine vs Human retrospective studies is endoscopist bias. It is usually generated because of human natural competitive spirit against machine or human relaxation because of AI-reliance. This can have an effect in the overall results.

The investigators perfomed colonoscopies with the use of a commercially available AI system to detect colonic polyps and recorded them during clinical routine. Additionally from March 2019 - May 2019, 120 colonoscopy videos were performed and captured prospectively without the use of AI.

In this study, the investigators plan to retrospectively compare those two video sets regarding the polyp detection rate, withdrawal time and polyp identification characteristics of the AI system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Colonoscopies for Polyp detection

Exclusion criteria

  • Colonoscopies for Inflammatory Bowel Disease (IBD).
  • Colonoscopies for work up of an active bleeding

Treatment and study plan

AI-Assisted Colonoscopy

Device

Colonoscopies performed with assistance of an AI tool that highlights the areas that are susceptible to be a polyp.

Primary outcomes

  1. Polyp detection rate comparison

    Time frame: 45 minutes

    Number of polyps detected divided by number of colonoscopies

  2. Mean withdrawal time comparison

    Time frame: 45 minutes

    Mean withdrawal time comparison

Secondary outcomes

  1. AI-Polyp bounding boxes - True Positive Evaluation

    Time frame: 45 minutes

    2 approaches: frame by frame analysis and temporal coherence analysis

  2. AI-Polyp bounding boxes - False Positive Quantitative Evaluation

    Time frame: 45 minutes

    3 approaches depending on window-time detection

  3. AI-Polyp bounding boxes - False Negative Evaluation

    Time frame: 45 minutes

    Number of by bounding box missed polyps

  4. Reaction Time Analysis

    Time frame: 45 minutes

    Comparison time of polyp detection in a human vs machine approach

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Acronym: RELIANT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Apr 8, 2021

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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