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/NCT05987033</url>
    </required_header>
    <id_info>
      <org_study_id>NVDX3-CLN01</org_study_id>
      <secondary_id>2022-002304-21</secondary_id>
      <nct_id>NCT05987033</nct_id>
    </id_info>
    <brief_title>Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.</brief_title>
    <official_title>A First-in-human Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novadip Biosciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>PrimeVigilance</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Data Investigation Company Europe (DICE)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Novadip Biosciences</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>
        Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from&#xD;
        distal radius fracture. NVDX3 will be implanted during a single surgical intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single arm, monocentric first-in-human PoC study in adult patients,&#xD;
        suffering from a distal radius fracture, treated during the surgical intervention with NVDX3,&#xD;
        an osteogenic implant from human allogeneic origin.&#xD;
  &#xD;
        As per standard of care, patients with DRF are followed up to 3 months post-intervention. In&#xD;
        the context of this trial, patient safety and IMP efficacy will be followed up to 12 months&#xD;
        post-implant surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Endpoint: evaluation of SAEs and NVDX3 related AEs</measure>
      <time_frame>Between screening (V1) and 12-months post- IS (V8)</time_frame>
      <description>Evaluation of all SAEs and NVDX3 related AEs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety: all acute SAEs and NVDX3 related AEs</measure>
      <time_frame>Between screening (V1) and 6 weeks post-IS (V5)</time_frame>
      <description>Description of all acute SAEs and NVDX3 related AEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety: all SAEs and NVDX3 related AEs</measure>
      <time_frame>Beyond 6 weeks (V5 excluded) until 12 months post-IS</time_frame>
      <description>Description of all SAEs and NVDX3 related AEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety: TEAEs</measure>
      <time_frame>a. Between screening and week 6 (V5 included) b. Between week 6 (V5 excluded) till month 12 (V8 included) c. through study completion</time_frame>
      <description>Description of Treatment Emergent AEs (TEAEs)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety: related and unexpected (S)AEs</measure>
      <time_frame>Between inclusion and 13 months post-IS</time_frame>
      <description>Description of related and unexpected (S)AEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety: AESI</measure>
      <time_frame>Between inclusion and 13 months post-IS</time_frame>
      <description>Description of AE of Special Interest (AESI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety: lab data</measure>
      <time_frame>Between inclusion and 13 months post-IS</time_frame>
      <description>Description of lab data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety: vital signs</measure>
      <time_frame>Between inclusion and 13 months post-IS</time_frame>
      <description>Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy: Radiological assessments on Computed Tomography (CT) data using the extended Lane and Sandhu Scoring tool (eLSS)</measure>
      <time_frame>At 3 and 12-months post-IS</time_frame>
      <description>Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy: Radiological assessments on X-ray using the eLSS tool</measure>
      <time_frame>At HD, 2-, 6-weeks, 3-,6- and 12-months post-IS</time_frame>
      <description>Radiological assessments on X-ray using the eLSS tool compared to the peri-operative x-ray acquisitions: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy: Clinical assessments</measure>
      <time_frame>At 2-,6 weeks, 3-, 6-, and 12-months post- IS</time_frame>
      <description>Following clinical assessment will be performed compared to HD: Grip strength measure with a hydraulic hand dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy: Clinical assessments</measure>
      <time_frame>At 2-,6 weeks, 3-, 6-, and 12-months post- IS</time_frame>
      <description>Following clinical assessment will be performed compared to HD: Modified Mayo Wrist Score (MMWS): A physician-based scoring evaluating the patients' pain, active flexion/extension arc, grip strength and ability to return to regular employment or activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy: Clinical assessments</measure>
      <time_frame>At 2-,6 weeks, 3-, 6-, and 12-months post- IS</time_frame>
      <description>Following clinical assessment will be performed compared to HD: PRWE Questionnaire: A patient reported scoring evaluating the patients' wrist pain and disability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy: NRS-pain</measure>
      <time_frame>At HD, 2-,6 weeks, 3-, 6-, and 12-months post-IS</time_frame>
      <description>NRS-pain, a patient reported scoring evaluating the patients' pain compared to Screening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory: Radiological assessments on Dual Energy CT data (DECT)</measure>
      <time_frame>At 3-, and 12-months post-IS</time_frame>
      <description>Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to NVDX3 density.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory: Radiological assessments on Dual Energy CT data (DECT)</measure>
      <time_frame>At 3-, and 12-months post-IS</time_frame>
      <description>Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of NVDX3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory: Radiological assessments on Dual Energy CT data (DECT)</measure>
      <time_frame>At 3-, and 12-months post-IS</time_frame>
      <description>Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of surrounding tissue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory: Radiological assessments on Dual Energy CT data (DECT)</measure>
      <time_frame>At 3-, and 12-months post-IS</time_frame>
      <description>Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to bone mineral density of native bone.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Distal Radius Fractures</condition>
    <arm_group>
      <arm_group_label>NVDX3 implant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NVDX3</intervention_name>
      <description>NVDX3 is implanted during a single surgical intervention.</description>
      <arm_group_label>NVDX3 implant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female patients within the age range of ≥18 years to ≤80 years.&#xD;
  &#xD;
            2. Patient diagnosed with DRF with confirmed:&#xD;
  &#xD;
                 1. Classification AO/ATO: C2 and C3 - Intra-articular &amp; multifragmentation.&#xD;
  &#xD;
                 2. Estimated volume of the targeted bone void should not exceed 5cc.&#xD;
  &#xD;
                 3. Availability of diagnostic AP and LAT X-ray or CT scan.&#xD;
  &#xD;
            3. Patient can undergo the targetted surgical intervention within 7 days post-DRF&#xD;
               diagnosis.&#xD;
  &#xD;
            4. Patient fulfills criteria for undergoing a surgical intervention.&#xD;
  &#xD;
            5. Patient has understood and accepted to participate in the study according to all study&#xD;
               procedures by signing the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Open DRF or closed DRF with increased infection risk.&#xD;
  &#xD;
            2. Injury to the median nerve.&#xD;
  &#xD;
            3. Previous fracture of the target distal radius.&#xD;
  &#xD;
            4. Documented disease limiting mobility and functional assessments (eg. Grip strength&#xD;
               test).&#xD;
  &#xD;
            5. Dependency on crutches or any comparable walking aids.&#xD;
  &#xD;
            6. Patient is overweight, has a BMI ≥35.&#xD;
  &#xD;
            7. Presence of clinically significant infection at the target implant site or systemic&#xD;
               infection.&#xD;
  &#xD;
            8. History of allergic reaction or any anticipated hypersensitivity to any of the&#xD;
               anticipated:&#xD;
  &#xD;
                 1. Osteosynthesis materials (PEEK plate and screws).&#xD;
  &#xD;
                 2. Anesthetic agents.&#xD;
  &#xD;
                 3. Components of the NVDX3 implant.&#xD;
  &#xD;
            9. Presence of any auto-immune disease, with exception of well controlled diabetes type-1&#xD;
               or II, or auto-immune thyroid disorders.&#xD;
  &#xD;
           10. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.&#xD;
  &#xD;
           11. Presence of an active tumor.&#xD;
  &#xD;
           12. Documented metabolic bone disease or any disorder, such as but not limited to&#xD;
               high-risk osteoporosis, that could interfere with the bone healing and bone&#xD;
               metabolism.&#xD;
  &#xD;
           13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or&#xD;
               bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants,&#xD;
               immunosuppressants or immunotherapy.&#xD;
  &#xD;
           14. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior&#xD;
               to screening.&#xD;
  &#xD;
           15. Any history of experimental therapy with another investigational drug within 60 days&#xD;
               prior to screening.&#xD;
  &#xD;
           16. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an&#xD;
               effective method of birth control3 during the course of the study. Note: WOCBP&#xD;
               including peri-menopausal women who have had a menstrual period within 1 year prior to&#xD;
               surgery have to have a negative pregnancy test before entering in the study.&#xD;
  &#xD;
           17. Any other psychosocial, mental and physical condition which, in the opinion of the&#xD;
               investigator, could interfere with the trial conduct, the patient's compliance or&#xD;
               influence interpretation of the results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Torsten Gerich, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Hospitalier du Luxembourg</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Denis Dufrane, MD</last_name>
      <phone>003210779220</phone>
      <email>clinical@novadip.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dieter Frijns, MSc</last_name>
      <phone>003210779220</phone>
      <email>clinical@novadip.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre Hospitalier de Luxembourg</name>
        <address>
          <city>Luxembourg</city>
          <zip>1210</zip>
          <country>Luxembourg</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Torsten Gerich, MD</last_name>
        <email>gerich.torsten@chl.lu</email>
      </contact>
    </location>
    <location_countries>
      <country>Luxembourg</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Radius Fractures</mesh_term>
      <mesh_term>Wrist Fractures</mesh_term>
    </condition_browse>
    <!-- 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/NCT05987033
  org study id: NVDX3-CLN01
  secondary id: 2022-002304-21
  nct id: NCT05987033
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from
        distal radius fracture. NVDX3 will be implanted during a single surgical intervention.
  This is a prospective, single arm, monocentric first-in-human PoC study in adult patients,
        suffering from a distal radius fracture, treated during the surgical intervention with NVDX3,
        an osteogenic implant from human allogeneic origin.
  
        As per standard of care, patients with DRF are followed up to 3 months post-intervention. In
        the context of this trial, patient safety and IMP efficacy will be followed up to 12 months
        post-implant surgery.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Endpoint: evaluation of SAEs and NVDX3 related AEs
  time frame: Between screening (V1) and 12-months post- IS (V8)
  description: Evaluation of all SAEs and NVDX3 related AEs
  measure: Safety: all acute SAEs and NVDX3 related AEs
  time frame: Between screening (V1) and 6 weeks post-IS (V5)
  description: Description of all acute SAEs and NVDX3 related AEs
  measure: Safety: all SAEs and NVDX3 related AEs
  time frame: Beyond 6 weeks (V5 excluded) until 12 months post-IS
  description: Description of all SAEs and NVDX3 related AEs
  measure: Safety: TEAEs
  time frame: a. Between screening and week 6 (V5 included) b. Between week 6 (V5 excluded) till month 12 (V8 included) c. through study completion
  description: Description of Treatment Emergent AEs (TEAEs)
  measure: Safety: related and unexpected (S)AEs
  time frame: Between inclusion and 13 months post-IS
  description: Description of related and unexpected (S)AEs
  measure: Safety: AESI
  time frame: Between inclusion and 13 months post-IS
  description: Description of AE of Special Interest (AESI)
  measure: Safety: lab data
  time frame: Between inclusion and 13 months post-IS
  description: Description of lab data
  measure: Safety: vital signs
  time frame: Between inclusion and 13 months post-IS
  description: Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure
  measure: Efficacy: Radiological assessments on Computed Tomography (CT) data using the extended Lane and Sandhu Scoring tool (eLSS)
  time frame: At 3 and 12-months post-IS
  description: Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score
  measure: Efficacy: Radiological assessments on X-ray using the eLSS tool
  time frame: At HD, 2-, 6-weeks, 3-,6- and 12-months post-IS
  description: Radiological assessments on X-ray using the eLSS tool compared to the peri-operative x-ray acquisitions: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score
  measure: Efficacy: Clinical assessments
  time frame: At 2-,6 weeks, 3-, 6-, and 12-months post- IS
  description: Following clinical assessment will be performed compared to HD: Grip strength measure with a hydraulic hand dynamometer
  measure: Efficacy: Clinical assessments
  time frame: At 2-,6 weeks, 3-, 6-, and 12-months post- IS
  description: Following clinical assessment will be performed compared to HD: Modified Mayo Wrist Score (MMWS): A physician-based scoring evaluating the patients' pain, active flexion/extension arc, grip strength and ability to return to regular employment or activities.
  measure: Efficacy: Clinical assessments
  time frame: At 2-,6 weeks, 3-, 6-, and 12-months post- IS
  description: Following clinical assessment will be performed compared to HD: PRWE Questionnaire: A patient reported scoring evaluating the patients' wrist pain and disability
  measure: Efficacy: NRS-pain
  time frame: At HD, 2-,6 weeks, 3-, 6-, and 12-months post-IS
  description: NRS-pain, a patient reported scoring evaluating the patients' pain compared to Screening
  measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
  time frame: At 3-, and 12-months post-IS
  description: Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to NVDX3 density.
  measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
  time frame: At 3-, and 12-months post-IS
  description: Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of NVDX3.
  measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
  time frame: At 3-, and 12-months post-IS
  description: Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of surrounding tissue.
  measure: Exploratory: Radiological assessments on Dual Energy CT data (DECT)
  time frame: At 3-, and 12-months post-IS
  description: Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to bone mineral density of native bone.
  arm group label: NVDX3 implant
  arm group type: Experimental
  intervention type: Drug
  intervention name: NVDX3
  description: NVDX3 is implanted during a single surgical intervention.
  arm group label: NVDX3 implant
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Torsten Gerich, MD
  role: Principal Investigator
  affiliation: Centre Hospitalier du Luxembourg
  last name: Denis Dufrane, MD
  phone: 003210779220
  email: clinical@novadip.com
  last name: Dieter Frijns, MSc
  phone: 003210779220
  email: clinical@novadip.com
  facility: 
  status: Recruiting
  contact: 
  country: Luxembourg
  responsible party type: Sponsor
  mesh term: Fractures, Bone
  mesh term: Radius Fractures
  mesh term: Wrist Fractures