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/NCT06020690</url>
    </required_header>
    <id_info>
      <org_study_id>YM-2023-003</org_study_id>
      <nct_id>NCT06020690</nct_id>
    </id_info>
    <brief_title>A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis</brief_title>
    <official_title>A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Enlight Medical Technologies (Shanghai) Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Enlight Medical Technologies (Shanghai) Co., Ltd</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>
        The goal of this clinical trial is to learn about the safety and effectiveness of Novabel&#xD;
        bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  The safety of this device for the chronic sinusitis&#xD;
  &#xD;
          -  The effectiveness of this device for the chronic sinusitis Participants will be&#xD;
             implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will&#xD;
             be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and&#xD;
             360 days after procedure.&#xD;
  &#xD;
        Researchers will compare test device and marketed device to see if the safety and&#xD;
        effectiveness between these two devices are non-inferior.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">September 9, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 9, 2024</primary_completion_date>
    <phase>N/A</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>non reintervention rate</measure>
      <time_frame>30 days</time_frame>
      <description>The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lund-Kennedy score</measure>
      <time_frame>30 days, 90 days, 180 days and 1 year</time_frame>
      <description>Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lund-Mackay score</measure>
      <time_frame>90 days</time_frame>
      <description>Each side of sinus is graded separately: 0 (no abnormality); 1 (partial opacification); 2 (complete opacification). If there is no frontal sinus (aplasia), the score is 0. Scores were calculated based on the results of a paranasal sinus CT scan 1-3 mm axial slice thickness with coronal and sagittal reconstruction. Result: score 0-24.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS score</measure>
      <time_frame>30 days, 90 days, 180 days and 1 year</time_frame>
      <description>A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sinus panty rate</measure>
      <time_frame>30 days, 90 days, 180 days and 1 year</time_frame>
      <description>as determined based on review of video endoscopic findings by an independent blinded surgeon</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>implantation successful rate</measure>
      <time_frame>immediately after the procedure</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>adverse event rate</measure>
      <time_frame>immediately after the procedure</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">93</enrollment>
    <condition>Chronic Sinusitis</condition>
    <arm_group>
      <arm_group_label>Novabel bioabsorbable steroid-releasing stent</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>marketed bioabsorbable steroid-releasing stent</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>bioabsorbable steroid-releasing stent</intervention_name>
      <description>The patient after functional endoscopic sinus surgery to treat their chronic sinusitis, the experimental device or active comparator device will be implanted to the sinus to prevent re-intervention (surgery or medicine).</description>
      <arm_group_label>Novabel bioabsorbable steroid-releasing stent</arm_group_label>
      <arm_group_label>marketed bioabsorbable steroid-releasing stent</arm_group_label>
      <other_name>functional endoscopic sinus surgery</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronic&#xD;
               rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral&#xD;
               ESS.&#xD;
  &#xD;
            -  Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay&#xD;
               [L-M] score of &lt;=3 on each side).&#xD;
  &#xD;
            -  Can understand the purpose of this study and will to join and finish all the follow up&#xD;
               according to the study. Sign the ICF.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Know history of allergy or intolerance to corticosteroids or mometasone furoate.&#xD;
  &#xD;
            2. The subject has a known allergic reaction or contraindication to the device material&#xD;
               and its degradation products (L-polylactic acid, racemic polylactic acid, lactide&#xD;
               lactate, lactic acid).&#xD;
  &#xD;
            3. Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.&#xD;
  &#xD;
            4. Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal&#xD;
               sinusitis.&#xD;
  &#xD;
            5. Glaucoma, ocular hypertension, posterior subcapsular cataracts.&#xD;
  &#xD;
            6. Known history of immune deficiency or concurrent condition requiring active&#xD;
               chemotherapy and/or immunotherapy management for the disease.&#xD;
  &#xD;
            7. Clinical evidence of disease or condition expected to compromise survival or ability&#xD;
               to complete follow-up assessments during the 360 day follow-up period.&#xD;
  &#xD;
            8. Current ESS including frontal sinus surgery is aborted for any reason.&#xD;
  &#xD;
            9. Pregnant or lactating female&#xD;
  &#xD;
           10. Investigator determination that the potential study subject is unable to comply with&#xD;
               study procedures and/or follow-up, or provided informed consent.&#xD;
  &#xD;
           11. Currently involved in another clinical study where that participation may conflict or&#xD;
               interfere with the treatment, follow-up or results of the clinical study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hu</last_name>
      <phone>08615221991087</phone>
      <email>echo_hu@enlight-medical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Qilu Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Li</last_name>
      </contact>
      <investigator>
        <last_name>Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bioabsorbable</keyword>
    <keyword>steroid-releasing stent</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sinusitis</mesh_term>
      <mesh_term>Chronic Disease</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/NCT06020690
  org study id: YM-2023-003
  nct id: NCT06020690
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the safety and effectiveness of Novabel
        bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to
        answer are:
  
          -  The safety of this device for the chronic sinusitis
  
          -  The effectiveness of this device for the chronic sinusitis Participants will be
             implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will
             be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and
             360 days after procedure.
  
        Researchers will compare test device and marketed device to see if the safety and
        effectiveness between these two devices are non-inferior.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: non reintervention rate
  time frame: 30 days
  description: The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.
  measure: Lund-Kennedy score
  time frame: 30 days, 90 days, 180 days and 1 year
  description: Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.
  measure: Lund-Mackay score
  time frame: 90 days
  description: Each side of sinus is graded separately: 0 (no abnormality); 1 (partial opacification); 2 (complete opacification). If there is no frontal sinus (aplasia), the score is 0. Scores were calculated based on the results of a paranasal sinus CT scan 1-3 mm axial slice thickness with coronal and sagittal reconstruction. Result: score 0-24.
  measure: VAS score
  time frame: 30 days, 90 days, 180 days and 1 year
  description: A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h.
  measure: sinus panty rate
  time frame: 30 days, 90 days, 180 days and 1 year
  description: as determined based on review of video endoscopic findings by an independent blinded surgeon
  measure: implantation successful rate
  time frame: immediately after the procedure
  measure: adverse event rate
  time frame: immediately after the procedure
  arm group label: Novabel bioabsorbable steroid-releasing stent
  arm group type: Experimental
  arm group label: marketed bioabsorbable steroid-releasing stent
  arm group type: Active Comparator
  intervention type: Device
  intervention name: bioabsorbable steroid-releasing stent
  description: The patient after functional endoscopic sinus surgery to treat their chronic sinusitis, the experimental device or active comparator device will be implanted to the sinus to prevent re-intervention (surgery or medicine).
  arm group label: Novabel bioabsorbable steroid-releasing stent
  arm group label: marketed bioabsorbable steroid-releasing stent
  other name: functional endoscopic sinus surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Li
  role: Principal Investigator
  affiliation: Qilu Hospital of Shandong University
  last name: Hu
  phone: 08615221991087
  email: echo_hu@enlight-medical.com
  facility: 
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Sinusitis
  mesh term: Chronic Disease