Computer-assisted Detection of Colonic Polyps

NCT ID: NCT02838888

Last Updated: 2017-04-11

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

2016-07-31

Study Completion Date

2017-08-31

Brief Summary

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Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect lesions. Recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. The program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. The program was now refined so that the respective structures can be highlighted during real time colonoscopy. The aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.

Detailed Description

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Conditions

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Colon Adenoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Routine colonoscopy Cohort

Patients receiving routine colonoscopy at the study site

Automatic polyp detection software

Intervention Type DEVICE

A computer program for the detection of colonic polyps will be used during colonoscopy

Interventions

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Automatic polyp detection software

A computer program for the detection of colonic polyps will be used during colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication for colonoscopy
* age ≥ 40 years

Exclusion Criteria

* American Society of Anesthesiologists class IV or higher
* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fraunhofer Institut Erlangen

UNKNOWN

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter Klare, MD

Role: CONTACT

+ 49 89 4140 ext. 9340

Stefan von Delius, Prof.

Role: CONTACT

+ 49 89 4140 ext. 5973

Facility Contacts

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Peter Klare, MD

Role: primary

+ 49 89 4140 ext. 9340

Stefan von Delius, Prof.

Role: backup

+ 49 89 4140 ext. 5973

References

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Klare P, Sander C, Prinzen M, Haller B, Nowack S, Abdelhafez M, Poszler A, Brown H, Wilhelm D, Schmid RM, von Delius S, Wittenberg T. Automated polyp detection in the colorectum: a prospective study (with videos). Gastrointest Endosc. 2019 Mar;89(3):576-582.e1. doi: 10.1016/j.gie.2018.09.042. Epub 2018 Oct 17.

Reference Type DERIVED
PMID: 30342029 (View on PubMed)

Other Identifiers

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KoloPol I

Identifier Type: -

Identifier Source: org_study_id

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