<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/NCT04456231</url>
  </required_header>
  <id_info>
    <org_study_id>126</org_study_id>
    <nct_id>NCT04456231</nct_id>
  </id_info>
  <brief_title>QR Code for Endoscopic Bowel Preparation</brief_title>
  <official_title>Effect of the Additional Use of a QR Code for More Effective Patient Education and High-quality Bowel Preparation in the Outpatient Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients presenting for colonoscopy at one of the participating centers will be asked to&#xD;
      participate in the present study after careful evaluation of inclusion and exclusion&#xD;
      criteria. Before inclusion, all patients have to sign the written informed consent. All&#xD;
      participating patients will receive PLENVU, a well-known and approved bowel preparation&#xD;
      agent. Patients are randomly assigned in two groups. Patients in group 1 are informed in&#xD;
      traditional way on how to use the bowel preparation agent. This way includes discussion with&#xD;
      the physician and nurse on how to use the bowel preparation agent and a written&#xD;
      documentation, highlighting the individual steps again. Patients in group 2 will receive in&#xD;
      addition a QR-code referring to an App, available for free in all App stores, explaining to&#xD;
      the patient in detail when and how to use the bowel preparation agent. The patient is&#xD;
      receiving the same questionnaire (please see attached) in both groups and asked to bring the&#xD;
      filled form on the day of the examination. Endoscopy is performed in standard way and&#xD;
      effectiveness of the bowel preparation is specifically highlighted by the physician on the&#xD;
      documentation report. Finally, data is analyzed regarding effectiveness of the QR code&#xD;
      regarding patient satisfaction, acceptability and quality of the bowel preparation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient education is of paramount importance for high acceptance and an adequate bowel&#xD;
      preparation. Using the QR code directly referring to the App for bowel preparation with&#xD;
      PLENVU might accelerate the discussion between the medical doctor and the patient and might&#xD;
      also improve the acceptance rate of the patients for the bowel preparation finally leading to&#xD;
      a more enhanced and effective bowel-preparation.&#xD;
&#xD;
      Patients undergoing screening or surveillance endoscopy will be prospectively included and&#xD;
      randomly assigned to one of the following groups: Group 1: App; Group 2: no-App Study end&#xD;
      points addressed below are prospectively assessed and evaluated for any significant changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Bowel Preparation Standard (BBPS)</measure>
    <time_frame>1 day</time_frame>
    <description>Bowel preparation according to international Standard, 1 is bad, 9 is very good, how many patients can Achieve BBPS with 9?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adenoma detection rate (ADR)</measure>
    <time_frame>1 day</time_frame>
    <description>How many adenomas will be detected during endoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Polyp detection rate (PDR)</measure>
    <time_frame>1 day</time_frame>
    <description>How many polyps will be detected during endoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time exposure to explain bowel preparation</measure>
    <time_frame>1 day</time_frame>
    <description>How much time will patients Need for preparation and how much time for discussing with the doctors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who are satisfied with preparation</measure>
    <time_frame>up to 1 month</time_frame>
    <description>How will doctors and patients like preparation with Plenvu and QR Code</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who Accept to repeat the examination (surveillance)</measure>
    <time_frame>up to 1 month</time_frame>
    <description>How many patients will come back for another endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cecal intubation rate</measure>
    <time_frame>1 day</time_frame>
    <description>How many endoscopies will reach the ceacum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedure time</measure>
    <time_frame>3 hours</time_frame>
    <description>How Long will endoscopy take compared to Standard technique</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">404</enrollment>
  <condition>Quality Standards in Colonoscopy</condition>
  <condition>Patient Education</condition>
  <condition>Acceptance of Bowel-preparation</condition>
  <arm_group>
    <arm_group_label>QR Code</arm_group_label>
    <description>Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. In Addition, this Group will receive a health app for better preparation and more Information regarding preparation and endoscopy itself.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no QR Code</arm_group_label>
    <description>Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. This Group will have no app and will have to receive Information in traditional ways.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Plenvu</intervention_name>
    <description>Patients will receive Plenvu for preparation of endoscopy</description>
    <arm_group_label>QR Code</arm_group_label>
    <arm_group_label>no QR Code</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: patients receiving traditional information how to prepare the colon Group 2:&#xD;
        patients receiving in addition a QR-code referring to an App, available for free in all App&#xD;
        stores, explaining to the patient in detail when and how to use the bowel preparation agent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Screening or surveillance colonoscopy&#xD;
&#xD;
               -  Age 18-85 years&#xD;
&#xD;
               -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Pregnancy or lactating&#xD;
&#xD;
               -  Lower gastrointestinal bleeding with hemodynamic instability&#xD;
&#xD;
               -  Bowel obstruction&#xD;
&#xD;
               -  ASA &gt;3&#xD;
&#xD;
               -  Not sufficiently corrected anticoagulation disorders&#xD;
&#xD;
               -  Plenvu must not be taken:&#xD;
&#xD;
                    -  if you are allergic (hypersensitive) to the active ingredients or any of the&#xD;
                       other ingredients of this medicine;&#xD;
&#xD;
                    -  if you have a blockage (obstruction) in the digestive tract.&#xD;
&#xD;
                    -  if you have a breakthrough (perforation) in the wall of the digestive tract;&#xD;
&#xD;
                    -  if you suffer from intestinal obstruction (Ileus);&#xD;
&#xD;
                    -  if you suffer from a disturbance of gastric emptying (e.g. gastroparesis,&#xD;
                       gastric retention);&#xD;
&#xD;
                    -  if you suffer from phenylketonuria. Phenylketonuria is a congenital&#xD;
                       metabolic disease in which phenylalanine cannot be processed by your body.&#xD;
                       Plenvu contains aspartame as a source of phenylalanine;&#xD;
&#xD;
                    -  if you suffer from glucose-6-phosphate dehydrogenase deficiency;&#xD;
&#xD;
                    -  if you suffer from acute colon enlargement (toxic megacolon).&#xD;
&#xD;
               -  Warnings and precautions&#xD;
&#xD;
                  o You should tell your doctor about the following circumstances before taking&#xD;
                  Plenvu:&#xD;
&#xD;
               -  if you have heart problems and/or arrhythmias;&#xD;
&#xD;
               -  if you have kidney problems and/or suffer from dehydration;&#xD;
&#xD;
               -  if you have stomach or intestinal problems, including intestinal inflammation;&#xD;
&#xD;
               -  if you have difficulty or discomfort when swallowing liquids;&#xD;
&#xD;
               -  if you have high or low levels of electrolyte (e.g. sodium, potassium);&#xD;
&#xD;
               -  if you have other diseases (e.g. convulsions).&#xD;
&#xD;
               -  Pregnancy and lactation o There are no data on the use of Plenvu during pregnancy&#xD;
                  or lactation and is therefore not recommended.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helmut Neumann, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Mainz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Helmut Neumann, Prof. Dr.</last_name>
    <phone>+4917866516595</phone>
    <email>helmut.neumann@unimedizin-mainz.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tanja Bender, M.A.</last_name>
    <phone>+496131</phone>
    <phone_ext>176838</phone_ext>
    <email>tanja.bender@unimedizin-mainz.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dr. Helmut Neumann</name>
      <address>
        <city>Bad Salzuflen</city>
        <state>Northrine-Westfalia</state>
        <zip>32105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helmut Neumann, Dr. med.</last_name>
      <phone>+495222</phone>
      <phone_ext>369836</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Prof. Helmut Neumann</investigator_full_name>
    <investigator_title>University Professor Dr. med.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Preliminary results for DDW (Deadline Dec, 1st, 2020) .&#xD;
Publication date:&#xD;
Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia).&#xD;
Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW&#xD;
Final manuscript: Gut -&gt; Am J Gastro -&gt; Endoscopy</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>First Data: January 2021 full Data: December 2021</ipd_time_frame>
    <ipd_access_criteria>Abstracts and Publication</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04456231
org study id: 126
nct id: NCT04456231
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients presenting for colonoscopy at one of the participating centers will be asked to
      participate in the present study after careful evaluation of inclusion and exclusion
      criteria. Before inclusion, all patients have to sign the written informed consent. All
      participating patients will receive PLENVU, a well-known and approved bowel preparation
      agent. Patients are randomly assigned in two groups. Patients in group 1 are informed in
      traditional way on how to use the bowel preparation agent. This way includes discussion with
      the physician and nurse on how to use the bowel preparation agent and a written
      documentation, highlighting the individual steps again. Patients in group 2 will receive in
      addition a QR-code referring to an App, available for free in all App stores, explaining to
      the patient in detail when and how to use the bowel preparation agent. The patient is
      receiving the same questionnaire (please see attached) in both groups and asked to bring the
      filled form on the day of the examination. Endoscopy is performed in standard way and
      effectiveness of the bowel preparation is specifically highlighted by the physician on the
      documentation report. Finally, data is analyzed regarding effectiveness of the QR code
      regarding patient satisfaction, acceptability and quality of the bowel preparation.
Patient education is of paramount importance for high acceptance and an adequate bowel
      preparation. Using the QR code directly referring to the App for bowel preparation with
      PLENVU might accelerate the discussion between the medical doctor and the patient and might
      also improve the acceptance rate of the patients for the bowel preparation finally leading to
      a more enhanced and effective bowel-preparation.

      Patients undergoing screening or surveillance endoscopy will be prospectively included and
      randomly assigned to one of the following groups: Group 1: App; Group 2: no-App Study end
      points addressed below are prospectively assessed and evaluated for any significant changes.
observational model: Cohort
time perspective: Prospective
measure: Boston Bowel Preparation Standard (BBPS)
time frame: 1 day
description: Bowel preparation according to international Standard, 1 is bad, 9 is very good, how many patients can Achieve BBPS with 9?
measure: Adenoma detection rate (ADR)
time frame: 1 day
description: How many adenomas will be detected during endoscopy
measure: Polyp detection rate (PDR)
time frame: 1 day
description: How many polyps will be detected during endoscopy
measure: time exposure to explain bowel preparation
time frame: 1 day
description: How much time will patients Need for preparation and how much time for discussing with the doctors
measure: Number of patients who are satisfied with preparation
time frame: up to 1 month
description: How will doctors and patients like preparation with Plenvu and QR Code
measure: Number of patients who Accept to repeat the examination (surveillance)
time frame: up to 1 month
description: How many patients will come back for another endoscopy
measure: cecal intubation rate
time frame: 1 day
description: How many endoscopies will reach the ceacum
measure: procedure time
time frame: 3 hours
description: How Long will endoscopy take compared to Standard technique
arm group label: QR Code
description: Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. In Addition, this Group will receive a health app for better preparation and more Information regarding preparation and endoscopy itself.
arm group label: no QR Code
description: Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. This Group will have no app and will have to receive Information in traditional ways.
intervention type: Drug
intervention name: Plenvu
description: Patients will receive Plenvu for preparation of endoscopy
arm group label: QR Code
arm group label: no QR Code
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helmut Neumann, Prof. Dr.
role: Principal Investigator
affiliation: University Medical Center Mainz
last name: Helmut Neumann, Prof. Dr.
phone: +4917866516595
email: helmut.neumann@unimedizin-mainz.de
last name: Tanja Bender, M.A.
phone: +496131
phone ext: 176838
email: tanja.bender@unimedizin-mainz.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Prof. Helmut Neumann
investigator title: University Professor Dr. med.
sharing ipd: Yes
ipd description: Preliminary results for DDW (Deadline Dec, 1st, 2020) .
Publication date:
Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia).
Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW
Final manuscript: Gut -> Am J Gastro -> Endoscopy
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: First Data: January 2021 full Data: December 2021
ipd access criteria: Abstracts and Publication