<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/NCT04409808</url>
  </required_header>
  <id_info>
    <org_study_id>S62660</org_study_id>
    <nct_id>NCT04409808</nct_id>
  </id_info>
  <brief_title>IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.</brief_title>
  <acronym>IRIS</acronym>
  <official_title>IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      To perform a safety study on the prototype IRIS vitrectomy device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      to determine the safety and effectiveness of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    because a device deficiency that occured in the Iris vitrectomy system (Alfa version)&#xD;
  </why_stopped>
  <start_date type="Actual">September 21, 2021</start_date>
  <completion_date type="Actual">November 7, 2022</completion_date>
  <primary_completion_date type="Actual">November 7, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of intra-operative adverse events that determine the safety of the surgery</measure>
    <time_frame>Intraoperative (surgery day)</time_frame>
    <description>complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Vitrectomy</condition>
  <arm_group>
    <arm_group_label>IRIS vitrectomy device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IRIS</intervention_name>
    <description>prototype IRIS vitrectomy device.</description>
    <arm_group_label>IRIS vitrectomy device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that are scheduled for vitrectomy surgery, regardless of the indication&#xD;
&#xD;
          -  Both vitrectomy-only and combined phaco-vitrectomy surgeries&#xD;
&#xD;
          -  Primary or repeat vitrectomy&#xD;
&#xD;
          -  General or local anesthesia, or combination&#xD;
&#xD;
          -  All ages&#xD;
&#xD;
          -  Informed consent (from parents in patients &lt;18 years old)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to obtain informed consent from patient (or from parents in children)&#xD;
&#xD;
          -  No post-operative 8 week visit is anticipated&#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>Peter Stalmans, PHd MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 21, 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/NCT04409808
org study id: S62660
nct id: NCT04409808
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To perform a safety study on the prototype IRIS vitrectomy device.
to determine the safety and effectiveness of the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: incidence of intra-operative adverse events that determine the safety of the surgery
time frame: Intraoperative (surgery day)
description: complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem
arm group label: IRIS vitrectomy device
arm group type: Experimental
description: all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device
intervention type: Device
intervention name: IRIS
description: prototype IRIS vitrectomy device.
arm group label: IRIS vitrectomy device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Stalmans, PHd MD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No
submitted: March 21, 2023