xml: <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/NCT06040112</url>
    </required_header>
    <id_info>
      <org_study_id>PC23DISV0050</org_study_id>
      <nct_id>NCT06040112</nct_id>
    </id_info>
    <brief_title>Effect of Atelocollagen Injection in Patients With Calcific Tendinitis</brief_title>
    <official_title>Effect of Atelocollagen Injection in Patients With Calcific Tendinitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hyungsuk Kim</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Catholic University of Korea</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Assess the clinical outcomes using atelocollagen injection in patients with calcific&#xD;
        tendinitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Suitable participants based on the selection/exclusion criteria are randomly assigned to&#xD;
        either the case group or the control group. Consent is given right before the procedure.&#xD;
  &#xD;
        Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine&#xD;
        and atelocollagen injection.&#xD;
  &#xD;
        Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine&#xD;
        injection.&quot;&#xD;
  &#xD;
        Clinical outcomes will be assessed with functional scores on 6 months after injection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Constant score (Shoulder function score)</measure>
      <time_frame>1, 3, 5 months</time_frame>
      <description>The Constant score is commonly used to evaluate the functional status of shoulder disorders and shows relatively high accuracy, reliability, and reproducibility. The evaluation is out of a total of 100 points: pain 15 points, daily activities 20 points, anterior elevation 10 points, lateral elevation 10 points, internal/external rotation each 10 points, and muscle strength 25 points</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Calcific Tendinitis of Shoulder</condition>
    <condition>Atelocollagen</condition>
    <arm_group>
      <arm_group_label>Atelocollagen injection group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Atelocollagen injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lidocain injection group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Lidocain injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tendoregen (Atelocollagen)</intervention_name>
      <description>Tendoregen (Atelocollagen) injection</description>
      <arm_group_label>Atelocollagen injection group</arm_group_label>
      <arm_group_label>Lidocain injection group</arm_group_label>
      <other_name>Lidocain</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients in whom calcification of 5mm or more is observed in plain radiographs.&#xD;
  &#xD;
            2. In cases where concomitant medication is administered continuously during the clinical&#xD;
               trial period, patients who have verified the exact prescribed medication taken within&#xD;
               the last week and agreed to maintain the same amount throughout the study period.&#xD;
  &#xD;
            3. Individuals who have agreed to participate in this study and have given written&#xD;
               consent themselves.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors,&#xD;
               or fractures.&#xD;
  &#xD;
                 -  Patients with hypersensitivity.&#xD;
  &#xD;
                      -  Patients with a history of anaphylactic reactions.&#xD;
  &#xD;
                           -  Patients with ongoing autoimmune diseases or a past medical history of&#xD;
                              such diseases, either in the patient or their family members.&#xD;
  &#xD;
                                -  Patients who are allergic to transplants. ⑥ Patients who are&#xD;
                                   allergic to porcine (pig) proteins.&#xD;
  &#xD;
                                   ⑦ Patients deemed unsuitable for this trial based on the judgment&#xD;
                                   of the trial administrator, such as those with mental illnesses.&#xD;
  &#xD;
                                   ⑧ Patients who have received intra-articular steroid or other&#xD;
                                   injection treatments within one month prior to the procedure&#xD;
                                   decision.&#xD;
  &#xD;
                                   ⑨ Patients who are on concomitant medications that include oral&#xD;
                                   steroids.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Eunpyeong St. Mary's Hospital, The Catholic University of Korea</name>
        <address>
          <city>Seoul</city>
          <zip>03341</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Hyungsuk Kim, M.D. Ph.D.</last_name>
        <phone>01074471541</phone>
        <email>tupacjr@daum.net</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
      <investigator_full_name>Hyungsuk Kim</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tendinopathy</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040112
  org study id: PC23DISV0050
  nct id: NCT06040112
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Assess the clinical outcomes using atelocollagen injection in patients with calcific
        tendinitis.
  Suitable participants based on the selection/exclusion criteria are randomly assigned to
        either the case group or the control group. Consent is given right before the procedure.
  
        Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine
        and atelocollagen injection.
  
        Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine
        injection."
  
        Clinical outcomes will be assessed with functional scores on 6 months after injection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Constant score (Shoulder function score)
  time frame: 1, 3, 5 months
  description: The Constant score is commonly used to evaluate the functional status of shoulder disorders and shows relatively high accuracy, reliability, and reproducibility. The evaluation is out of a total of 100 points: pain 15 points, daily activities 20 points, anterior elevation 10 points, lateral elevation 10 points, internal/external rotation each 10 points, and muscle strength 25 points
  arm group label: Atelocollagen injection group
  arm group type: Experimental
  description: Atelocollagen injection
  arm group label: Lidocain injection group
  arm group type: Placebo Comparator
  description: Lidocain injection
  intervention type: Device
  intervention name: Tendoregen (Atelocollagen)
  description: Tendoregen (Atelocollagen) injection
  arm group label: Atelocollagen injection group
  arm group label: Lidocain injection group
  other name: Lidocain
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 69 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: The Catholic University of Korea
  investigator full name: Hyungsuk Kim
  investigator title: Assistant professor
  mesh term: Tendinopathy
  mesh term: Lidocaine
  sharing ipd: No