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

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

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.

Study Overview

• Status: Unknown
• Conditions: ERCP

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be outpatients and inpatients undergoing ERCP at the Memorial Hermann Hospital Texas Medical Center. All patients will be seen by any one of the investigators either in the outpatient clinic or during inpatient consultation on hospitalized patients.

The physicians and Nurse technicians will be evaluating the performance of the TIP duodenoscope on these patients undergoing ERCP.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing ERCP by formally trained Endoscopists; 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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Wake Forest University Health Sciences; Instituto Ecuatoriano de Enfermedades Digestivas

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-20-0408