<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/NCT04441320</url>
  </required_header>
  <id_info>
    <org_study_id>URO-02</org_study_id>
    <nct_id>NCT04441320</nct_id>
  </id_info>
  <brief_title>Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture</brief_title>
  <official_title>Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      A prospective, multicenter and controlled study to observe the efficacy and safety of coated&#xD;
      metal ureteral stent in the treatment of radiation induced ureteral stricture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patency rate</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Number of patients evaluated with hydronephrosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Indwelling time</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Number of months of the implant in the ureter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device related serious adverse events</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Number of device related serious adverse events</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ureteral Stricture</condition>
  <condition>Hydronephrosis</condition>
  <condition>Radiation Exposure</condition>
  <arm_group>
    <arm_group_label>CMUS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coated metal ureteral stent is indwelled.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DJS group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Double-J stent is indwelled</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coated metal ureteral stent(CMUS)</intervention_name>
    <description>Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.</description>
    <arm_group_label>CMUS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double-J stent(DJS)</intervention_name>
    <description>Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.</description>
    <arm_group_label>DJS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of ureteral stricture and hydronephrosis.&#xD;
&#xD;
          2. Previous history of radiation therapy.&#xD;
&#xD;
          3. Must be able to tolerate surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Combine with hypertonic neurogenic bladder (except for patients with long-term&#xD;
             indwelling catheter).&#xD;
&#xD;
          2. Colon resection surgery patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mingrui Wang</last_name>
    <phone>19801286883</phone>
    <email>wangmingrui1995@pku.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peiking university people's hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mingrui Wang, Doctor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Huhao</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>radiation induced ureteral stricture</keyword>
  <keyword>coated metal ureteral stent</keyword>
  <keyword>safety</keyword>
  <keyword>efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydronephrosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <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/NCT04441320
org study id: URO-02
nct id: NCT04441320
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, multicenter and controlled study to observe the efficacy and safety of coated
      metal ureteral stent in the treatment of radiation induced ureteral stricture.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patency rate
time frame: Up to 36 months
description: Number of patients evaluated with hydronephrosis
measure: Indwelling time
time frame: Up to 36 months
description: Number of months of the implant in the ureter
measure: Device related serious adverse events
time frame: Up to 36 months
description: Number of device related serious adverse events
arm group label: CMUS group
arm group type: Experimental
description: Coated metal ureteral stent is indwelled.
arm group label: DJS group
arm group type: Other
description: Double-J stent is indwelled
intervention type: Device
intervention name: Coated metal ureteral stent(CMUS)
description: Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.
arm group label: CMUS group
intervention type: Device
intervention name: Double-J stent(DJS)
description: Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.
arm group label: DJS group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mingrui Wang
phone: 19801286883
email: wangmingrui1995@pku.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Huhao
investigator title: Associate Professor
mesh term: Hydronephrosis
mesh term: Constriction, Pathologic
sharing ipd: No