Computer-assisted Detection of Colonic Polyps

NCT02838888 | Unknown

• 1 other identifier: KoloPol I
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Adenoma

Keywords

Adenoma; computer; automatic; polyp; detection

Outcome Measures

Primary Outcomes (1)

• Polyp detection

  After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks) it can be determined whether the resected specimen contained polyp histology or not.

  up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

Study Arms (1)

Routine colonoscopy Cohort

Patients receiving routine colonoscopy at the study site

Device: Automatic polyp detection software

Interventions

Automatic polyp detection software DEVICE

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

Routine colonoscopy Cohort

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving colonoscopy at the study site are eligible for participation.

You may qualify if:

• Indication for colonoscopy
• age ≥ 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Fraunhofer Institut Erlangen: collaborator

Study Sites (1)

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

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 30342029 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colon polyps

MeSH Terms

Conditions

Adenoma; Polyps

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Peter Klare, MD

CONTACT

+ 49 89 4140; peter.klare@tum.de

Stefan von Delius, Prof.

CONTACT

+ 49 89 4140; stefan_ruckert@yahoo.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)