Computer-aided Detection of Colorectal Polyps

NCT ID: NCT04359355

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-05-31

Brief Summary

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In this observational pilot study, we assess the diagnostic performance of an artificial intelligence sytem for automated detection of colorectal polyps.

Detailed Description

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During standard colonoscopy, a substantial number of colorectal polyps can be missend. As shown in a recent meta-analysis, miss rates for adenomas can reach up to 26%. In this study, it is tested whether an artificial intelligence system that highlights colorectal polyps during screening or surveillance colonoscopy in real time can lead to an increased detection of colorectal polyps during the examination.

Conditions

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Adenoma Colon Polyp of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Artificial Intelligence

Artificial Intelligence System for Detection of colorectal polyps

Intervention Type DEVICE

In this group, an artificial Intelligence System will be used for computer-aided diagnosis of colorectal polyps. Diagnostic Performance of the artificial intelligence System for detection of polyps will be compared against Operator-based detection in the same group

Interventions

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Artificial Intelligence System for Detection of colorectal polyps

In this group, an artificial Intelligence System will be used for computer-aided diagnosis of colorectal polyps. Diagnostic Performance of the artificial intelligence System for detection of polyps will be compared against Operator-based detection in the same group

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Screening or surveillance colonoscopy

Exclusion Criteria

* known or suspected inflammatory bowel disease
* uncontrolled coagulopathy
* known polyps or referral for polypectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Timo Rath

Professor of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Erlangen

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Timo Rath, MD

Role: CONTACT

49 9131 85 ext. 45041

Facility Contacts

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Timo Rath, Professor of Endoscopy

Role: primary

49 9131 ext. 85 45041

References

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Pfeifer L, Neufert C, Leppkes M, Waldner MJ, Hafner M, Beyer A, Hoffman A, Siersema PD, Neurath MF, Rath T. Computer-aided detection of colorectal polyps using a newly generated deep convolutional neural network: from development to first clinical experience. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e662-e669. doi: 10.1097/MEG.0000000000002209.

Reference Type DERIVED
PMID: 34034272 (View on PubMed)

Other Identifiers

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CAID

Identifier Type: -

Identifier Source: org_study_id

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