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

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01242995
First received: November 16, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Disorders of the Pancreatobiliary System
 Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of the Thin Scope/Anchoring Balloon Cholangiopancreatoscopy System for Disorders fo the Pancreatobiliary System

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: November 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pancreatobiliary disorders/thin scope
All patients will be evaluated with cholangioscopy and/or pancreatoscopy using the thin scope.
 Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope
Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy using the thin scope system.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242995

Contacts
Contact: Peter Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands at UF endoscopy Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Peter Draganov, MD     352-273-9400     peter.draganov@mediicne.ufl.edu    
Principal Investigator: Peter Draganov, MD            
Sub-Investigator: Chris Forsmark, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01242995     History of Changes
Other Study ID Numbers: Thin Scope
Study First Received: November 16, 2010
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013