Computer-assisted Detection of Colonic Polyps

• Conditions: Colon Adenoma
• Interventions: Device: Automatic polyp detection software

• Registration Number: NCT02838888
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Primary Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Routine colonoscopy Cohort	Automatic polyp detection software	Patients receiving routine colonoscopy at the study site

Primary Outcome Measures

Name	Time	Method
Polyp detection	up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)	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.

Trial Locations

Locations (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Bayern, Germany