<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/NCT03230357</url>
  </required_header>
  <id_info>
    <org_study_id>Branden-edug</org_study_id>
    <nct_id>NCT03230357</nct_id>
  </id_info>
  <brief_title>Research on the Localization Accuracy of PICC Guided by EDUG in Real World</brief_title>
  <official_title>Research on the Localization Accuracy of PICC Guided by EDUG in Real World</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Branden Med.Device Co.,Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong Branden Med.Device Co.,Ltd</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>
      This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved,&#xD;
      carry out the guidance of EDUG PICC standardized operation at the same period. Each center&#xD;
      assists to use app to collect research data.The experimental data will be collected,&#xD;
      processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG&#xD;
      will be evaluated according to the results (like the rate of once in place, the number of&#xD;
      adjustment times before X-ray, the length of time during the whole catheter placement, the&#xD;
      ectopic incidence during PICC first implantation and so on, the special content can be seen&#xD;
      in the next indicator section)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Anticipated">August 2, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the rate of once in place</measure>
    <time_frame>From the date of admitting to hospital until completion of the trial, up to 6 months.</time_frame>
    <description>judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the number of adjustment times before X-ray</measure>
    <time_frame>From the date of admitting until discharge to hospital, up to 14 days.</time_frame>
    <description>the totally number of adjustment times during the once operation guided by EDUG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the length of time during the whole catheter placement before X-ray</measure>
    <time_frame>From the date of admitting until discharge to hospital, up to 14 days.</time_frame>
    <description>the whole length of time during the once operation guided by EDUG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of cathetering times after X-ray</measure>
    <time_frame>From the date of admitting until discharge to hospital, up to 14 days.</time_frame>
    <description>the totally number of cathetering times during the operation guided by EDUG until the cather tip can be guided to the right location</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>record the adverse events</measure>
    <time_frame>0,24,48,72 hours and 7days after completing the whole cathetering operation; Every 7 days from completing the whole cathering operation until tube drawing whichever came first, assessed up to 1 year</time_frame>
    <description>the adverse events including bleeding, infection , thrombosis and so on</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptance</measure>
    <time_frame>From the date of admitting until discharge to hospital, up to 14 days.</time_frame>
    <description>The patient who is in line with the discharge criteria and intends to enter the study shall record whether or not he has agreed to accept the operation plan and complete the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the convenience of the operation</measure>
    <time_frame>From the date of admitting until discharge to hospital, up to 14 days.</time_frame>
    <description>App questionnaire was used to collect the convenience and comfort of PICC operators</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Peripherally Inserted Central Catheter</condition>
  <arm_group>
    <arm_group_label>PICC guided by EDUG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICC(Peripherally Inserted Central Catheter)guided by ECG Doppler ultrasonic Guidance（EDUG),EDUG is a combination device which can be used for selecting the right vein and precise positioning for the catheter tip during the PICC cathetering.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICC guided by EDUG</intervention_name>
    <description>ECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world</description>
    <arm_group_label>PICC guided by EDUG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient≥18 years old&#xD;
&#xD;
          2. Follow the doctor's advice,patients who need to be placed PICC for the first time.&#xD;
&#xD;
          3. No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart&#xD;
             disease and other P wave abnormalities, severe heart block, etc.&#xD;
&#xD;
          4. Patients who did not participate in other clinical studies；&#xD;
&#xD;
          5. Patients who volunteer to participate the clinical study, sign the informed consent&#xD;
             and cooperate with the clinical follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have partial deformity or scar formation&#xD;
&#xD;
          2. Patients whose puncture site were infected or damaged&#xD;
&#xD;
          3. Patients who have sclerosis or the cord like change of the vein&#xD;
&#xD;
          4. Patients have compressed vessel by tumor&#xD;
&#xD;
          5. Patients who are confirmed or suspected having infection, bacteremia, or sepsis&#xD;
             related to the catheter&#xD;
&#xD;
          6. Patients whose size are not fit to insert the PICC&#xD;
&#xD;
          7. Patients who are confirmed or suspected sensitive to silica gel&#xD;
&#xD;
          8. Patients who have history of radiotherapy in the pre-insertion section&#xD;
&#xD;
          9. Patients who have history of venous thrombosis, trauma, or vascular surgery&#xD;
&#xD;
         10. Patients who have superior vena cava syndrome&#xD;
&#xD;
         11. Patients who were always not following up with the doctors&#xD;
&#xD;
         12. Patients who have severe peripheral edema&#xD;
&#xD;
         13. Patients who may be required a high flow of fluid infusion, hemodialysis, pacemaker,&#xD;
             crutches or A-V fistulation&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Qilu Hospital Of Shangdong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03230357
org study id: Branden-edug
nct id: NCT03230357
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved,
      carry out the guidance of EDUG PICC standardized operation at the same period. Each center
      assists to use app to collect research data.The experimental data will be collected,
      processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG
      will be evaluated according to the results (like the rate of once in place, the number of
      adjustment times before X-ray, the length of time during the whole catheter placement, the
      ectopic incidence during PICC first implantation and so on, the special content can be seen
      in the next indicator section)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: the rate of once in place
time frame: From the date of admitting to hospital until completion of the trial, up to 6 months.
description: judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray
measure: the number of adjustment times before X-ray
time frame: From the date of admitting until discharge to hospital, up to 14 days.
description: the totally number of adjustment times during the once operation guided by EDUG
measure: the length of time during the whole catheter placement before X-ray
time frame: From the date of admitting until discharge to hospital, up to 14 days.
description: the whole length of time during the once operation guided by EDUG
measure: the number of cathetering times after X-ray
time frame: From the date of admitting until discharge to hospital, up to 14 days.
description: the totally number of cathetering times during the operation guided by EDUG until the cather tip can be guided to the right location
measure: record the adverse events
time frame: 0,24,48,72 hours and 7days after completing the whole cathetering operation; Every 7 days from completing the whole cathering operation until tube drawing whichever came first, assessed up to 1 year
description: the adverse events including bleeding, infection , thrombosis and so on
measure: Patient acceptance
time frame: From the date of admitting until discharge to hospital, up to 14 days.
description: The patient who is in line with the discharge criteria and intends to enter the study shall record whether or not he has agreed to accept the operation plan and complete the operation
measure: the convenience of the operation
time frame: From the date of admitting until discharge to hospital, up to 14 days.
description: App questionnaire was used to collect the convenience and comfort of PICC operators
arm group label: PICC guided by EDUG
arm group type: Experimental
description: PICC(Peripherally Inserted Central Catheter)guided by ECG Doppler ultrasonic Guidance（EDUG),EDUG is a combination device which can be used for selecting the right vein and precise positioning for the catheter tip during the PICC cathetering.
intervention type: Device
intervention name: PICC guided by EDUG
description: ECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world
arm group label: PICC guided by EDUG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No