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

This study has been withdrawn prior to enrollment.
(The device was withdrawn from clinical use)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242995
First Posted: November 17, 2010
Last Update Posted: May 7, 2015
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.
Information provided by (Responsible Party):
University of Florida
November 16, 2010
November 17, 2010
May 7, 2015
May 2015
May 2015   (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 ]
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
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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.
 
Withdrawn
0
May 2015
May 2015   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01242995
Thin Scope
No
Not Provided
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University of Florida
University of Florida
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Principal Investigator: Peter Draganov, MD University of Florida
University of Florida
May 2015