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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This study has been withdrawn prior to enrollment.
(The device was withdrawn from clinical use)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:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01242995
First received: November 16, 2010
Last updated: May 6, 2015
Last verified: May 2015

November 16, 2010
May 6, 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 ] [ 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.
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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
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*   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.
Both
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
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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

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