NCT04335318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

April 2, 2020

Last Update Submit

April 7, 2021

Conditions

Colonic Polyp

Keywords

Deep LearningPolyp detection rateCNN

Outcome Measures

Primary Outcomes (2)

  • Polyp detection rate comparison

    Number of polyps detected divided by number of colonoscopies

    45 minutes

  • Mean withdrawal time comparison

    Mean withdrawal time comparison

    45 minutes

Secondary Outcomes (4)

  • AI-Polyp bounding boxes - True Positive Evaluation

    45 minutes

  • AI-Polyp bounding boxes - False Positive Quantitative Evaluation

    45 minutes

  • AI-Polyp bounding boxes - False Negative Evaluation

    45 minutes

  • Reaction Time Analysis

    45 minutes

Study Arms (2)

Colonoscopy with AI-assistance group

EXPERIMENTAL

Colonoscopies were performed with AI-assistance.

Device: AI-assisted colonoscopy

Standard Colonoscopy group

NO INTERVENTION

Standard clinical procedure

Interventions

AI-assisted colonoscopyDEVICE

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

Colonoscopy with AI-assistance group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colonoscopies for Polyp detection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Hann, PD Dr. Med

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

May 1, 2020

Primary Completion

August 31, 2020

Study Completion

October 1, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)