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Real Life AI in Polyp Detection

Real Life AI in Polyp Detection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04335318
Acronym
RELIANT
Enrollment
230
Registered
2020-04-06
Start date
2020-05-01
Completion date
2020-10-01
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp

Keywords

Deep Learning, Polyp detection rate, CNN

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Colonoscopies for Polyp detection

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Polyp detection rate comparison45 minutesNumber of polyps detected divided by number of colonoscopies
Mean withdrawal time comparison45 minutesMean withdrawal time comparison

Secondary

MeasureTime frameDescription
AI-Polyp bounding boxes - True Positive Evaluation45 minutes2 approaches: frame by frame analysis and temporal coherence analysis
AI-Polyp bounding boxes - False Positive Quantitative Evaluation45 minutes3 approaches depending on window-time detection
AI-Polyp bounding boxes - False Negative Evaluation45 minutesNumber of by bounding box missed polyps
Reaction Time Analysis45 minutesComparison time of polyp detection in a human vs machine approach

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026