Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope
May 6, 2015 updated by: University of Florida
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Subject is 18 years or older
- Subject has clinical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangioscopy and/or pancreatoscopy
- Subject must be able to give informed consent.
Exclusion Criteria:
- Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- The subject is unable to give informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pancreatobiliary disorders/thin scope
All patients will be evaluated with cholangioscopy and/or pancreatoscopy using the thin scope.
|
Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy using the thin scope system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
use of a thin endoscope system for the evaluation and/or treatment of pancreatobiliary disorders.
Time Frame: approxiamtely 2-4 hours
|
approxiamtely 2-4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
November 16, 2010
First Submitted That Met QC Criteria
November 16, 2010
First Posted (Estimate)
November 17, 2010
Study Record Updates
Last Update Posted (Estimate)
May 7, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Thin Scope
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.