<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/NCT04472091</url>
  </required_header>
  <id_info>
    <org_study_id>57046</org_study_id>
    <secondary_id>IDE G200111</secondary_id>
    <nct_id>NCT04472091</nct_id>
  </id_info>
  <brief_title>Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain</brief_title>
  <official_title>Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrew Picel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this investigation is to evaluate the safety of the geniculate artery&#xD;
      embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain&#xD;
      caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial&#xD;
      embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order&#xD;
      to evaluate the effect on knee pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2023</start_date>
  <completion_date type="Anticipated">November 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2024</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>Number of patients with treatment related adverse events</measure>
    <time_frame>1 month post GAE</time_frame>
    <description>Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with treatment related adverse events</measure>
    <time_frame>6 months post GAE</time_frame>
    <description>Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with treatment related adverse events</measure>
    <time_frame>12 months post GAE</time_frame>
    <description>Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with treatment related adverse events</measure>
    <time_frame>24 months post GAE</time_frame>
    <description>Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline pain scores</measure>
    <time_frame>Baseline to 1 month post GAE</time_frame>
    <description>Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents &quot;no pain&quot; and 100 mm represents &quot;worse possible pain.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline pain scores</measure>
    <time_frame>Baseline to 6 months post GAE</time_frame>
    <description>Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents &quot;no pain&quot; and 100 mm represents &quot;worse possible pain.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline pain scores</measure>
    <time_frame>Baseline to 12 months post GAE</time_frame>
    <description>Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents &quot;no pain&quot; and 100 mm represents &quot;worse possible pain.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline pain scores</measure>
    <time_frame>Baseline 24 months post GAE</time_frame>
    <description>Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents &quot;no pain&quot; and 100 mm represents &quot;worse possible pain.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline knee function scores</measure>
    <time_frame>Baseline to 1 month post GAE</time_frame>
    <description>Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of &quot;0&quot; indicates no symptoms and &quot;4&quot; indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline knee function scores</measure>
    <time_frame>Baseline to 6 months post GAE</time_frame>
    <description>Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of &quot;0&quot; indicates no symptoms and &quot;4&quot; indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline knee function scores</measure>
    <time_frame>Baseline to 12 months post GAE</time_frame>
    <description>Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of &quot;0&quot; indicates no symptoms and &quot;4&quot; indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline knee function scores</measure>
    <time_frame>Baseline to 24 months post GAE</time_frame>
    <description>Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of &quot;0&quot; indicates no symptoms and &quot;4&quot; indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Pain Chronic</condition>
  <condition>Knee Pain Swelling</condition>
  <condition>Knee Arthritis</condition>
  <condition>Arterial Occlusion</condition>
  <arm_group>
    <arm_group_label>Genicular artery embolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study.&#xD;
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Genicular artery embolization (GAE)</intervention_name>
    <description>Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).</description>
    <arm_group_label>Genicular artery embolization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provide informed consent&#xD;
&#xD;
          2. Age ≥ 40 years&#xD;
&#xD;
          3. Moderate to severe knee pain (VAS &gt;40 mm)&#xD;
&#xD;
          4. Pain refractory to 3 months of conservative treatments, including at least one of the&#xD;
             following:&#xD;
&#xD;
               -  a. Anti-inflammatory medications&#xD;
&#xD;
               -  b. Physical therapy&#xD;
&#xD;
               -  c. Intra-articular injections&#xD;
&#xD;
          5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease&#xD;
&#xD;
          6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI).&#xD;
&#xD;
          7. Ineligibility or refusal of surgical management.&#xD;
&#xD;
          8. Local knee tenderness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Rheumatoid or infectious arthritis&#xD;
&#xD;
          2. Advanced lower extremity atherosclerosis that would limit selective angiography&#xD;
&#xD;
          3. Local knee infection&#xD;
&#xD;
          4. Prior knee surgery (excluding arthroscopic/meniscal interventions)&#xD;
&#xD;
          5. Uncorrectable coagulopathy (INR&gt;1.8, platelets&lt;50,000/µL)&#xD;
&#xD;
          6. Iodine allergy resulting in anaphylaxis&#xD;
&#xD;
          7. Chronic renal insufficiency (serum creatinine &gt;2 mg/dL)&#xD;
&#xD;
          8. Life expectancy less than 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew C Picel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew C Picel, MD</last_name>
      <phone>650-736-6109</phone>
      <email>apicel@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 22, 2023</last_update_submitted>
  <last_update_submitted_qc>April 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Andrew Picel</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Knee osteoarthritis</keyword>
  <keyword>Genicular artery embolization</keyword>
  <keyword>Geniculate artery embolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04472091
org study id: 57046
secondary id: IDE G200111
nct id: NCT04472091
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The objective of this investigation is to evaluate the safety of the geniculate artery
      embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain
      caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial
      embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order
      to evaluate the effect on knee pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with treatment related adverse events
time frame: 1 month post GAE
description: Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
measure: Number of patients with treatment related adverse events
time frame: 6 months post GAE
description: Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
measure: Number of patients with treatment related adverse events
time frame: 12 months post GAE
description: Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
measure: Number of patients with treatment related adverse events
time frame: 24 months post GAE
description: Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
measure: Mean change from baseline pain scores
time frame: Baseline to 1 month post GAE
description: Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
measure: Mean change from baseline pain scores
time frame: Baseline to 6 months post GAE
description: Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
measure: Mean change from baseline pain scores
time frame: Baseline to 12 months post GAE
description: Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
measure: Mean change from baseline pain scores
time frame: Baseline 24 months post GAE
description: Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
measure: Mean change from baseline knee function scores
time frame: Baseline to 1 month post GAE
description: Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
measure: Mean change from baseline knee function scores
time frame: Baseline to 6 months post GAE
description: Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
measure: Mean change from baseline knee function scores
time frame: Baseline to 12 months post GAE
description: Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
measure: Mean change from baseline knee function scores
time frame: Baseline to 24 months post GAE
description: Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
arm group label: Genicular artery embolization
arm group type: Experimental
description: Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.
intervention type: Device
intervention name: Genicular artery embolization (GAE)
description: Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).
arm group label: Genicular artery embolization
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew C Picel, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Stanford University
investigator full name: Andrew Picel
investigator title: Assistant Clinical Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Arterial Occlusive Diseases
sharing ipd: No