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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT04447976
Collaborator
Wake Forest University Health Sciences (Other), Instituto Ecuatoriano de Enfermedades Digestivas (Other)
100
Enrollment
1
Location
24.9
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Multi-center Prospective Study to Evaluate Performance of Disposable TIP Duodenoscope Designed to Prevent Future Outbreak Related to Contaminated Duodenoscope.
    Actual Study Start Date :
    Jun 2, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Jul 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Disposable TIP duodenoscope survey evaluation performance [During procedure]

      To evaluate overall performance of disposable TIP duodenoscope through a survey regarding its performance during various steps of ERCP procedure.

    2. 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. [during procedure]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Hermann Hospital Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Nirav Thosani, MD, MHA, The University of Texas Health Science Center, Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nirav C Thosani, Associate Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT04447976
    Other Study ID Numbers:
    • HSC-MS-20-0408
    First Posted:
    Jun 25, 2020
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021

    Study Results

    No Results Posted as of Jan 12, 2021