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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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 2016
Estimated Primary Completion Date: February 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014