NCT04447976

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• ERCP

Timeline

• Start date: 2020-06-02
• Primary completion: 2021-10-01
• Completion: 2022-07-01
• First posted: 2020-06-25
• Last updated: 2021-01-12

Locations

1 site across 1 country: United States