Recruiting

Disposable Elevator Cap Duodenoscope

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04447976

Conditions

ERCP

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT04447976

Start date

Jun 2, 2020

Status verified date

Jan, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Oct, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Disposable TIP duodenoscope survey evaluation performance [ Time Frame: 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. [ Time Frame: during procedure ]

Central Contacts and Locations

Central contacts

Prithvi Patil, MS

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

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Prithvi Patil, MS

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jan 12, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2021-01-12.