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/NCT05999006</url>
    </required_header>
    <id_info>
      <org_study_id>EP-02</org_study_id>
      <nct_id>NCT05999006</nct_id>
    </id_info>
    <brief_title>Safety and Feasibility of the ELIOS System in POAG Patients</brief_title>
    <official_title>A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Elios Vision, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Elios Vision, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce&#xD;
        intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle&#xD;
        glaucoma (POAG)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications</measure>
      <time_frame>12 Months</time_frame>
      <description>Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean Change in DIOP from baseline on the same or fewer medications</measure>
      <time_frame>12 Months</time_frame>
      <description>Mean Change in DIOP from baseline on the same or fewer medications</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Glaucoma, Primary Open Angle</condition>
    <arm_group>
      <arm_group_label>ELIOS Procedure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ELIOS Procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ELIOS Procedure</intervention_name>
      <description>Treatment with the ELIOS System</description>
      <arm_group_label>ELIOS Procedure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of mild to moderate POAG&#xD;
  &#xD;
            -  Medicated IOP of &lt;=24 mmHg&#xD;
  &#xD;
            -  Shaffer angle grade of III or IV&#xD;
  &#xD;
            -  CD ratio &lt;=0.8&#xD;
  &#xD;
            -  At least 45 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Closed-angle and secondary glaucomas&#xD;
  &#xD;
            -  Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery&#xD;
  &#xD;
            -  Cannot undergo medication washout in the study eye&#xD;
  &#xD;
            -  Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80&#xD;
               Known corticosteroid responder Pregnant or nursing women; or women of childbearing&#xD;
               potential not using medically acceptable birth control&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Iqbal (Ike) Ahmed, MD</last_name>
      <role>Study Director</role>
      <affiliation>Prism Eye Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rupali Nangia</last_name>
      <phone>714-227-6151</phone>
      <email>rupali@eliosvision.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 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>Glaucoma</mesh_term>
      <mesh_term>Glaucoma, Open-Angle</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/NCT05999006
  org study id: EP-02
  nct id: NCT05999006
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce
        intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle
        glaucoma (POAG)
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
  time frame: 12 Months
  description: Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
  measure: Mean Change in DIOP from baseline on the same or fewer medications
  time frame: 12 Months
  description: Mean Change in DIOP from baseline on the same or fewer medications
  arm group label: ELIOS Procedure
  arm group type: Experimental
  description: ELIOS Procedure
  intervention type: Device
  intervention name: ELIOS Procedure
  description: Treatment with the ELIOS System
  arm group label: ELIOS Procedure
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Iqbal (Ike) Ahmed, MD
  role: Study Director
  affiliation: Prism Eye Institute
  last name: Rupali Nangia
  phone: 714-227-6151
  email: rupali@eliosvision.com
  responsible party type: Sponsor
  mesh term: Glaucoma
  mesh term: Glaucoma, Open-Angle
  sharing ipd: No