Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate overall performance of disposable TIP duodenoscopes and get insight from end-users regarding its performance during various steps of ERCP procedure as well as ease and feasibility of pre-procedure duodenoscope set up and post procedure manual cleaning as well as reprocessing. Research design: This is a prospective observational multi-center study. Procedure used: During ERCP Risks and potential benefits: There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future. Importance of knowledge that may reasonably be expected to result: The quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement. More specifically in the quality metrics sector we will be able to see what is already in place and steps we will undertake that will be beneficial for physicians.

Detailed Description
-----------------
This is a prospective study to evaluate performance of disposable TIP duodenoscopes. Scope is designed to facilitate effective reprocessing of duodenoscope and thus prevent future outbreaks related to contaminated duodenoscope despite standard reprocessing. This is a multi-center study being performed at the University of Texas Health Science Center, Wake Forest Baptist Health and Institute of Gastroenterology in Ecuador. The study will enroll a total of 100 patients who undergo ERCP. The study is purely observational as it will collect clinical success and information of the TIP duodenoscope.

Official Title
-----------------
A Multi-center Prospective Study to Evaluate Performance of Disposable TIP Duodenoscope Designed to Prevent Future Outbreak Related to Contaminated Duodenoscope.

Conditions
-----------------
ERCP

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patients undergoing ERCP. Patient has a clinical indication for ERCP. Exclusion Criteria: Any patients less than 18 years old undergoing ERCP as medical necessary procedure. Patients who refuse to consent for ERCP procedure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing ERCP by formally trained Endoscopists<br>No intervention has been used and this is an observational study of evaluation of a TIP duodenoscope performance overall. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposable TIP duodenoscope survey evaluation performance | To evaluate overall performance of disposable TIP duodenoscope through a survey regarding its performance during various steps of ERCP procedure. | During procedure | 
| To get insight from end-users such as physicians, fellows in training and nurse technicians regarding the disposable TIP duodenoscope performance during various steps of ERCP procedure through a questionnaire provided. | To evaluate overall performance of disposable TIP duodenoscopes through a survey and get insight from end-users such as physicians, fellows in training and nurse technicians regarding its performance during various steps of ERCP procedure. | during procedure |