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Trial record 41 of 305 for:    Recruiting, Not yet recruiting, Available Studies | "Adenoma"

Computer-assisted Detection of Colonic Polyps (KoloPol I)

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ClinicalTrials.gov Identifier: NCT02838888
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Fraunhofer Institut Erlangen
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment
Colon Adenoma Device: Automatic polyp detection software

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Routine colonoscopy Cohort
Patients receiving routine colonoscopy at the study site
Device: Automatic polyp detection software
A computer program for the detection of colonic polyps will be used during colonoscopy




Primary Outcome Measures :
  1. Polyp detection [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Colon polyps


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving colonoscopy at the study site are eligible for participation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838888


Contacts
Contact: Peter Klare, MD + 49 89 4140 ext 9340 peter.klare@tum.de
Contact: Stefan von Delius, Prof. + 49 89 4140 ext 5973 stefan_ruckert@yahoo.de

Locations
Germany
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München Recruiting
Munich, Bayern, Germany, 81675
Contact: Peter Klare, MD    + 49 89 4140 ext 9340    peter.klare@tum.de   
Contact: Stefan von Delius, Prof.    + 49 89 4140 ext 5973    stefan_ruckert@yahoo.de   
Sponsors and Collaborators
Technische Universität München
Fraunhofer Institut Erlangen

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02838888     History of Changes
Other Study ID Numbers: KoloPol I
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Technische Universität München:
Adenoma
computer
automatic
polyp
detection

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms