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

The University of Texas System (UT)

Status: Unknown

Conditions: ERCP

Study type: Observational

Funder types: Other

Identifiers

NCT04447976

HSC-MS-20-0408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients undergoing ERCP by formally trained Endoscopists

Description:

No intervention has been used and this is an observational study of evaluation of a TIP duodenoscope performance overall.