Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope

This study is currently recruiting participants.
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01242995
First received: November 16, 2010
Last updated: April 3, 2014
Last verified: April 2014

November 16, 2010
April 3, 2014
November 2010
February 2016   (final data collection date for primary outcome measure)
use of a thin endoscope system for the evaluation and/or treatment of pancreatobiliary disorders. [ Time Frame: approxiamtely 2-4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01242995 on ClinicalTrials.gov Archive Site
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Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope
Prospective Evaluation of the Clinical Utility of the Thin Scope/Anchoring Balloon Cholangiopancreatoscopy System for Disorders fo the Pancreatobiliary System

The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy system for the medical care of pancreatic and/or biliary disorders.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who have a medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for this study.

Disorders of the Pancreatobiliary System
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope
Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy using the thin scope system.
pancreatobiliary disorders/thin scope
All patients will be evaluated with cholangioscopy and/or pancreatoscopy using the thin scope.
Intervention: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is 18 years or older
  2. Subject has clinical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangioscopy and/or pancreatoscopy
  3. Subject must be able to give informed consent.

Exclusion Criteria:

  1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
  2. The subject is unable to give informed consent.
Both
18 Years and older
No
Contact: Peter Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu
United States
 
NCT01242995
Thin Scope
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Peter Draganov, MD University of Florida
University of Florida
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP