Computer-assisted Detection of Colonic Polyps

Colon Adenoma Clinical Trial

— KoloPol I  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838888
• Other study ID #: KoloPol I
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: April 8, 2017
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: April 2017
• Source: Technische Universität München
• Contact: Peter Klare, MD
• Phone: + 49 89 4140
• Email: peter.klare[@]tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma

Intervention

Device:
• Automatic polyp detection software
A computer program for the detection of colonic polyps will be used during colonoscopy

Locations

Country	Name	City	State
Germany	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	Munich	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	Fraunhofer Institut Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)