<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/NCT03756662</url>
  </required_header>
  <id_info>
    <org_study_id>ARGOS-SC01</org_study_id>
    <secondary_id>CIV-18-07-025065</secondary_id>
    <nct_id>NCT03756662</nct_id>
  </id_info>
  <brief_title>Performance and Safety of the ARGOS-SC01 Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery</brief_title>
  <acronym>ARGOS-SC01</acronym>
  <official_title>A Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Implandata Ophthalmic Products GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CRO Dr. med. Kottmann GmbH &amp; Co. KG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Implandata Ophthalmic Products GmbH</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>
      The purpose of this study is to evaluate both the safety and feasibility of the surgical&#xD;
      implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety&#xD;
      and usability of the ARGOS-SC implant and system in the year following the implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as a prospective, open-label, multicenter, single-arm clinical&#xD;
      investigation. Subjects will be followed up at regular intervals for one year following&#xD;
      implantation to collect safety and performance information. Enrollment will be halted at&#xD;
      every serious adverse device event (SADE).&#xD;
&#xD;
      The sensor device is intended to be permanently implanted suprachoroidal in the human eye&#xD;
      during non-penetrating glaucoma surgery and is used in conjunction with the hand-held&#xD;
      MESOGRAPH reading device to telemetrically measure the intraocular pressure (IOP) of the&#xD;
      implanted eye.&#xD;
&#xD;
      The sample size calculation was based on the study's dual purpose of establishing safety and&#xD;
      comparability of IOP measurements with the ARGOS-SC system to those made with GAT and DCT.&#xD;
      IOP measurements will be made with all devices at various time points, resulting in a within&#xD;
      individual control for IOP variables. Based on these calculations (performance, safety) and&#xD;
      considering possible drop-outs, the exploratory investigation will enroll 24 patients. The&#xD;
      minimum number of measurements required to hold the performance claim is approx. 120. With&#xD;
      multiple (&gt;8) measurements with either method (ARGOS, GAT) per patient, a sufficient number&#xD;
      of paired measurements (in total &gt;&gt;120 measurement pairs) will be available to show&#xD;
      equivalence of the methods (primary objective).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">February 18, 2021</completion_date>
  <primary_completion_date type="Actual">February 18, 2021</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>Prospective, open-label, single arm, multicenter</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance</measure>
    <time_frame>Day 1 to Day 360</time_frame>
    <description>Level of Agreement between measurements made using GAT, Pascal DCT and the ARGOS-SC system (IOP in mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Number of patients experiencing a device-related SAE (SADE)</measure>
    <time_frame>During implantation and 12 months follow-up</time_frame>
    <description>Number of patients experiencing a device-related SAE (SADE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence, nature, severity and seriousness of observed adverse events and adverse device events</measure>
    <time_frame>During implantation and 12 months follow-up</time_frame>
    <description>Incidence, nature, severity and seriousness of observed adverse events and adverse device events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>Day 2 to Day 360</time_frame>
    <description>Repeatability of the ARGOS-SC measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>During implantation and 12 months follow-up</time_frame>
    <description>Incidence, nature and seriousness of observed device malfunctions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility</measure>
    <time_frame>Day 1</time_frame>
    <description>User acceptance of the ARGOS-SC implantation procedure by means of evaluation of implantation procedure questionnaires (surgeons) on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility</measure>
    <time_frame>Day 2 to Day 360</time_frame>
    <description>User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility</measure>
    <time_frame>Day 2 to Day 360</time_frame>
    <description>User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)</description>
  </secondary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Glaucoma</condition>
  <condition>Open Angle Glaucoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ARGOS-SC suprachoroidal pressure sensor</intervention_name>
    <description>The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects able to understand the informed consent and willing to participate as&#xD;
             evidenced by providing informed consent.&#xD;
&#xD;
          2. Male or female aged ≥ 18 years on the day of screening Female subjects of childbearing&#xD;
             potential (not surgically sterilized or more than one year post-menopausal) must be&#xD;
             willing to use adequate contraception throughout the trial and must have a negative&#xD;
             pregnancy test (urine beta-hCG) within 24 hours prior to ARGOS-SC pressure sensor&#xD;
             implantation.&#xD;
&#xD;
          3. Diagnosis of open angle glaucoma requiring a non-penetrating glaucoma surgery (NPGS).&#xD;
             The medical indication for a non-penetrating glaucoma surgery must be given&#xD;
             irrespective of the study participation. Potential study patients will be solicited&#xD;
             for participation in the clinical trial only after the patient has given consent to&#xD;
             the non-penetrating glaucoma operation.&#xD;
&#xD;
          4. Subjects able and willing to attend all scheduled visits and comply with all study&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications for a non-penetrating glaucoma surgery&#xD;
&#xD;
               -  Neovascular glaucoma, primary and secondary angle closure glaucoma&#xD;
&#xD;
               -  Condition after previous glaucoma incisional surgery&#xD;
&#xD;
               -  IOP &gt; 40 mmHg&#xD;
&#xD;
          2. Myopia (&gt; -6 dpt) or hypermetropia (&gt; +4 dpt)&#xD;
&#xD;
          3. Axis length &lt; 22 mm or &gt; 26 mm&#xD;
&#xD;
          4. Exudative age-related macular degeneration, instable macular degeneration 30 days&#xD;
             prior to inclusion, or macular edema&#xD;
&#xD;
          5. Acute retinal detachment&#xD;
&#xD;
          6. Uncontrolled Diabetes Mellitus (DM) with manifestation of moderate to severe&#xD;
             non-proliferative diabetic Retinopathy (DR) or proliferative DR.&#xD;
&#xD;
          7. History or evidence of severe active inflammatory eye diseases (i.e. uveitis,&#xD;
             retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-SC&#xD;
             implantation&#xD;
&#xD;
          8. Ocular surgery procedure(s) (excluding selective laser trabeculoplasty and peripheral&#xD;
             iridotomy) within 6 months (cataract surgery within 3 months) prior to ARGOS-SC&#xD;
             implantation in the study eye that can affect the assessment of IOP by Goldmann&#xD;
             Applanation tonometry&#xD;
&#xD;
          9. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or&#xD;
             IOP by Goldmann Applanation tonometry/Pascal Dynamic Contour Tonometry (e.g. choroidal&#xD;
             hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy)&#xD;
&#xD;
         10. Existence of other active medical eye implant and/or other active medical implants in&#xD;
             the head/neck region&#xD;
&#xD;
         11. Difficulties or complications during NPGS procedure or implantation of ARGOS-SC&#xD;
             sensor, as assessed by surgeon (e.g. perforation of trabeculo-descement's membrane;&#xD;
             excessive aqueous filtration through TDM leading to shallow anterior chamber;&#xD;
             excessive bleeding; choroidal detachment)&#xD;
&#xD;
         12. Severe generalized disease resulting in a life expectancy shorter than a year&#xD;
&#xD;
         13. Currently pregnant or breastfeeding&#xD;
&#xD;
         14. Participation in any study involving an investigational drug or device within the past&#xD;
             30 days or ongoing participation in a study with an investigational drug or device&#xD;
&#xD;
         15. Patients who are not suitable for the study based on the surgeon's evaluation&#xD;
&#xD;
         16. Patients unable or unwilling to understand or comply with required study procedures&#xD;
&#xD;
         17. Patients with psychiatric disorders influencing their judgement or autonomy&#xD;
&#xD;
         18. Subject and/or an immediate family member is an employee of the investigational site&#xD;
             directly affiliated with this study, the sponsor or the contract research&#xD;
             organization.&#xD;
&#xD;
         19. Enrollment of the fellow eye in this clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Szurman, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitäts-Augenklinik</name>
      <address>
        <city>Bochum</city>
        <zip>44892</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenklinik der LMU München</name>
      <address>
        <city>München</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach</name>
      <address>
        <city>Sulzbach</city>
        <zip>66280</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi</name>
      <address>
        <city>Lausanne</city>
        <zip>1006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-penetrating glaucoma surgery</keyword>
  <keyword>Open angle glaucoma</keyword>
  <keyword>Intraocular pressure measurements</keyword>
  <keyword>Suprachoroidal pressure sensor</keyword>
  <keyword>ARGOS-SC</keyword>
  <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>
  <pending_results>
    <submitted>March 7, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03756662
org study id: ARGOS-SC01
secondary id: CIV-18-07-025065
nct id: NCT03756662
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate both the safety and feasibility of the surgical
      implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety
      and usability of the ARGOS-SC implant and system in the year following the implantation.
This study is designed as a prospective, open-label, multicenter, single-arm clinical
      investigation. Subjects will be followed up at regular intervals for one year following
      implantation to collect safety and performance information. Enrollment will be halted at
      every serious adverse device event (SADE).

      The sensor device is intended to be permanently implanted suprachoroidal in the human eye
      during non-penetrating glaucoma surgery and is used in conjunction with the hand-held
      MESOGRAPH reading device to telemetrically measure the intraocular pressure (IOP) of the
      implanted eye.

      The sample size calculation was based on the study's dual purpose of establishing safety and
      comparability of IOP measurements with the ARGOS-SC system to those made with GAT and DCT.
      IOP measurements will be made with all devices at various time points, resulting in a within
      individual control for IOP variables. Based on these calculations (performance, safety) and
      considering possible drop-outs, the exploratory investigation will enroll 24 patients. The
      minimum number of measurements required to hold the performance claim is approx. 120. With
      multiple (>8) measurements with either method (ARGOS, GAT) per patient, a sufficient number
      of paired measurements (in total >>120 measurement pairs) will be available to show
      equivalence of the methods (primary objective).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, open-label, single arm, multicenter
primary purpose: Diagnostic
masking: None (Open Label)
measure: Performance
time frame: Day 1 to Day 360
description: Level of Agreement between measurements made using GAT, Pascal DCT and the ARGOS-SC system (IOP in mmHg)
measure: Safety: Number of patients experiencing a device-related SAE (SADE)
time frame: During implantation and 12 months follow-up
description: Number of patients experiencing a device-related SAE (SADE)
measure: Safety: Incidence, nature, severity and seriousness of observed adverse events and adverse device events
time frame: During implantation and 12 months follow-up
description: Incidence, nature, severity and seriousness of observed adverse events and adverse device events
measure: Performance
time frame: Day 2 to Day 360
description: Repeatability of the ARGOS-SC measurement
measure: Performance
time frame: During implantation and 12 months follow-up
description: Incidence, nature and seriousness of observed device malfunctions
measure: Utility
time frame: Day 1
description: User acceptance of the ARGOS-SC implantation procedure by means of evaluation of implantation procedure questionnaires (surgeons) on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)
measure: Utility
time frame: Day 2 to Day 360
description: User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)
measure: Utility
time frame: Day 2 to Day 360
description: User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree)
intervention type: Device
intervention name: ARGOS-SC suprachoroidal pressure sensor
description: The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Szurman, Prof.
role: Principal Investigator
affiliation: Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
submitted: March 7, 2023