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/NCT05967091</url>
    </required_header>
    <id_info>
      <org_study_id>2023-01</org_study_id>
      <nct_id>NCT05967091</nct_id>
    </id_info>
    <brief_title>Ryme Medical TLD Pilot Study</brief_title>
    <official_title>Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ryme Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ryme Medical, Inc.</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>
        Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients&#xD;
        with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a prospective, multi-center, non-randomized study to evaluate the safety and&#xD;
        performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive&#xD;
        pulmonary disease (COPD)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>
      <intervention_model_description>Single-arm, non-randomized</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device Safety</measure>
      <time_frame>30 Days</time_frame>
      <description>Serious adverse events associated with the Ryme Medical Lung Denervation System</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Device Success</measure>
      <time_frame>Day 0</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Technical Success</measure>
      <time_frame>Day 0</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <arm_group>
      <arm_group_label>Targeted Lung Denervation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Targeted Lung Denervation</intervention_name>
      <description>Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System</description>
      <arm_group_label>Targeted Lung Denervation</arm_group_label>
      <other_name>TLD</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Symptomatic chronic obstructive pulmonary disease&#xD;
  &#xD;
            -  ≥40 years of age&#xD;
  &#xD;
            -  Smoking history of at least 10 pack years&#xD;
  &#xD;
            -  Candidate for bronchoscopy in the opinion of the Investigator&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Recent COPD exacerbation or respiratory infection&#xD;
  &#xD;
            -  Prior lung intervention with device in place&#xD;
  &#xD;
            -  Pulmonary nodule or malignancy requiring treatment&#xD;
  &#xD;
            -  Current chemotherapy or radiation therapy and/or has received treatment within 6&#xD;
               months&#xD;
  &#xD;
            -  Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not&#xD;
               prescribed by a physician&#xD;
  &#xD;
            -  Clinically significant serious or unstable medical conditions (e.g., heart disease&#xD;
               requiring treatment, uncontrolled diabetes)&#xD;
  &#xD;
            -  Pregnant, nursing, or intent to become pregnant during study duration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COPD</keyword>
    <keyword>Dyspnea</keyword>
    <keyword>Lung denervation</keyword>
    <keyword>Bronchoscopic intervention</keyword>
    <keyword>Lung disease</keyword>
    <keyword>Lung diseases, obstructive</keyword>
    <keyword>Respiratory tract diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_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/NCT05967091
  org study id: 2023-01
  nct id: NCT05967091
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients
        with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study
  The study is a prospective, multi-center, non-randomized study to evaluate the safety and
        performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive
        pulmonary disease (COPD)
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single-arm, non-randomized
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Device Safety
  time frame: 30 Days
  description: Serious adverse events associated with the Ryme Medical Lung Denervation System
  measure: Device Success
  time frame: Day 0
  measure: Technical Success
  time frame: Day 0
  arm group label: Targeted Lung Denervation
  arm group type: Experimental
  description: Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System
  intervention type: Device
  intervention name: Targeted Lung Denervation
  description: Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
  arm group label: Targeted Lung Denervation
  other name: TLD
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No