Status:

UNKNOWN

Resect and Discard Extension to FICE of NIcE Classification

Lead Sponsor:

Istituto Clinico Humanitas

Collaborating Sponsors:

Universitaire Ziekenhuizen KU Leuven

Royal Alexandra Hospital

Conditions:

Hyperplastic Polyps

Adenomatous Polyps

Eligibility:

All Genders

Brief Summary

The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplast...

Detailed Description

1. In order to create a video-library of endoscopic cases, patients undergoing screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified ...

Eligibility Criteria

Inclusion

  • The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
  • The patient is at satisfactory risk to undergo abdominal surgery;
  • The patient must understand and provide written consent for the procedure.

Exclusion

  • Patients with inflammatory bowel disease;
  • Patients with a personal history of polyposis syndrome;
  • Patients with diverticulitis or toxic megacolon;
  • Patients with a history of radiation therapy to abdomen or pelvis.
  • Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
  • Personal history of coagulation disorders or use of anticoagulants
  • Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Key Trial Info

Start Date :

May 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2014

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT02263144

Start Date

May 1 2014

End Date

December 1 2014

Last Update

October 13 2014

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Dept of Gastroenterology and Endoscopy, University Hospital

Leuven, Belgium

2

Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon

Lyon, France

3

Department of Medicine I, University of Erlangen-Nürnberg Medical School

Erlangen, Germany

4

Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder

Regensburg, Germany

Resect and Discard Extension to FICE of NIcE Classification | DecenTrialz