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Electronic Chromoendoscopy for Polyp Characterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118856
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.

Condition or disease Intervention/treatment
Colorectal Polyp Diagnostic Test: Prediction of Histology

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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : May 31, 2018

Group/Cohort Intervention/treatment
HD-WLE
Intervention: Prediction of polyp histology with HD-WLE
Diagnostic Test: Prediction of Histology
The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC

EC
Intervention: Prediction of polyp histology with EC
Diagnostic Test: Prediction of Histology
The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC




Primary Outcome Measures :
  1. Accuracy of predicting histology with EC [ Time Frame: 1 year ]
    Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing screening or surveillance colonoscopy
Criteria

Inclusion Criteria:

  • patients undergoing screening or surveillance colonoscopy
  • written informed consent

Exclusion Criteria:

  • inadequate bowel preparation
  • polyposis syndromes
  • history of colectomy
  • use of anticoagulants

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): NCT03118856


Locations
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Germany
University Hospital Erlangen
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Timo Rath, MD University Hospital Erlangen
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03118856    
Other Study ID Numbers: TR-001
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical