<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447976</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-20-0408</org_study_id>
    <nct_id>NCT04447976</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice</brief_title>
  <acronym>deCAP</acronym>
  <official_title>A Multi-center Prospective Study to Evaluate Performance of Disposable TIP Duodenoscope Designed to Prevent Future Outbreak Related to Contaminated Duodenoscope.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Ecuatoriano de Enfermedades Digestivas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To evaluate overall performance of disposable TIP duodenoscopes and get insight from&#xD;
      end-users regarding its performance during various steps of ERCP procedure as well as ease&#xD;
      and feasibility of pre-procedure duodenoscope set up and post procedure manual cleaning as&#xD;
      well as reprocessing.&#xD;
&#xD;
      Research design: This is a prospective observational multi-center study. Procedure used:&#xD;
      During ERCP&#xD;
&#xD;
      Risks and potential benefits: There are no risks associated with this study as it is a&#xD;
      retrospective chart review. Potential benefits include the knowledge gained from this study&#xD;
      which may be of help to patients in the future.&#xD;
&#xD;
      Importance of knowledge that may reasonably be expected to result: The quality of health care&#xD;
      which will be crucial to identify patterns of competence and identify areas of continued&#xD;
      improvement. More specifically in the quality metrics sector we will be able to see what is&#xD;
      already in place and steps we will undertake that will be beneficial for physicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study to evaluate performance of disposable TIP duodenoscopes. Scope is&#xD;
      designed to facilitate effective reprocessing of duodenoscope and thus prevent future&#xD;
      outbreaks related to contaminated duodenoscope despite standard reprocessing.&#xD;
&#xD;
      This is a multi-center study being performed at the University of Texas Health Science&#xD;
      Center, Wake Forest Baptist Health and Institute of Gastroenterology in Ecuador. The study&#xD;
      will enroll a total of 100 patients who undergo ERCP. The study is purely observational as it&#xD;
      will collect clinical success and information of the TIP duodenoscope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disposable TIP duodenoscope survey evaluation performance</measure>
    <time_frame>During procedure</time_frame>
    <description>To evaluate overall performance of disposable TIP duodenoscope through a survey regarding its performance during various steps of ERCP procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>during procedure</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>ERCP</condition>
  <arm_group>
    <arm_group_label>Patients undergoing ERCP by formally trained Endoscopists</arm_group_label>
    <description>No intervention has been used and this is an observational study of evaluation of a TIP duodenoscope performance overall.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be outpatients and inpatients undergoing ERCP at the Memorial Hermann&#xD;
        Hospital Texas Medical Center. All patients will be seen by any one of the investigators&#xD;
        either in the outpatient clinic or during inpatient consultation on hospitalized patients.&#xD;
&#xD;
        The physicians and Nurse technicians will be evaluating the performance of the TIP&#xD;
        duodenoscope on these patients undergoing ERCP.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult patients undergoing ERCP.&#xD;
&#xD;
          -  Patient has a clinical indication for ERCP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patients less than 18 years old undergoing ERCP as medical necessary procedure.&#xD;
&#xD;
          -  Patients who refuse to consent for ERCP procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nirav Thosani, MD, MHA</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Prithvi Patil, MS</last_name>
    <phone>713-500-6456</phone>
    <email>prithvi.b.patil@uth.tmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prithvi Patil, MS</last_name>
      <phone>713-500-6456</phone>
      <email>prithvi.b.patil@uth.tmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Nirav C Thosani</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447976
org study id: HSC-MS-20-0408
nct id: NCT04447976
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Disposable TIP duodenoscope survey evaluation performance
time frame: During procedure
description: To evaluate overall performance of disposable TIP duodenoscope through a survey regarding its performance during various steps of ERCP procedure.
measure: 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
description: 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.
arm group label: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nirav Thosani, MD, MHA
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Prithvi Patil, MS
phone: 713-500-6456
email: prithvi.b.patil@uth.tmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Nirav C Thosani
investigator title: Associate Professor