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

NCT04447976 | Unknown

• 1 other identifier: HSC-MS-20-0408
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ERCP

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any adult patients undergoing ERCP.
• Patient has a clinical indication for ERCP.

You may not qualify if:

• Any patients less than 18 years old undergoing ERCP as medical necessary procedure.
• Patients who refuse to consent for ERCP procedure.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Wake Forest University Health Sciences: collaborator
• Instituto Ecuatoriano de Enfermedades Digestivas: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Nirav Thosani, MD, MHA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prithvi Patil, MS

CONTACT

713-500-6456; prithvi.b.patil@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 25, 2020
• Study Start: June 2, 2020
• Primary Completion: October 1, 2021
• Study Completion: July 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (1)