<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/NCT01695720</url>
  </required_header>
  <id_info>
    <org_study_id>VisionScope VSI-001</org_study_id>
    <nct_id>NCT01695720</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee</brief_title>
  <acronym>VSI-001</acronym>
  <official_title>Trial Comparing VisionScope Imaging (VSI) With Magnetic Resonance Imaging (MRI) in the Diagnosis of Suggestive Clinical Symptoms for Meniscus and Articular Cartilage Injuries in the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VisionScope Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VisionScope Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for&#xD;
      pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).&#xD;
      The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.&#xD;
&#xD;
      The hypothesis is the VisionScope Imaging system will be able to provide direct visualization&#xD;
      and diagnostic images of inside the joint capsule space without fluid distention in the knee.&#xD;
      This study will provide valuable feedback on the ability of the VisionScope system to provide&#xD;
      physicians with the information they need to make a definitive diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to accumulate efficacy data on the VisionScope Imaging&#xD;
      System (VSI) for pre-operative diagnoses when it is used to provide illumination and&#xD;
      visualization of articular cavities. The study will analyze the VisionScope system's accuracy&#xD;
      compared to MRI in diagnosing and confirming meniscus tears, chondral defects, loose bodies,&#xD;
      minor arthritis, and/or any articular or capsular trauma.&#xD;
&#xD;
      The hypothesis of the study is that the VisionScope System will be able to obtain direct&#xD;
      visualization and diagnostic images of the intercapsular space without fluid distention in&#xD;
      the knee. This study will provide feedback on the ability of the VisionScope system to&#xD;
      potentially eliminate the need for MRI scans. Additionally, a cost-analysis comparison&#xD;
      between the use of VSI vs. MRI for the diagnosis of orthopaedic knee injuries will be&#xD;
      conducted. Finally, the study will help develop an algorithm of potential use for the VSI&#xD;
      system in the management of knee pathologies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Accuracy</measure>
    <time_frame>1 day</time_frame>
    <description>Diagnostic accuracy will be assessed during the time of the procedure. There will be no patient followup in this study. Radiologists, post procedure, will compare/contrast the diagnostic findings of a patient's MRI, VSI and Dx Arthroscopy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Meniscus Tears</condition>
  <condition>Loose Bodies</condition>
  <condition>Articular Osteoarthritis</condition>
  <condition>Articular or Capsular Trauma</condition>
  <arm_group>
    <arm_group_label>VisionScope Imaging (VSI) Exam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A VisionScope Imaging (VSI) Exam is diagnostic arthroscopic procedure. Through a natural or surgical opening, an endoscope is inserted through a cannula to illuminate and visualize the interior cavity of a joint.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VisionScope Imaging (VSI) Exam</intervention_name>
    <description>The VisionScope Imaging (VSI) Exam [the system itself] is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening.</description>
    <arm_group_label>VisionScope Imaging (VSI) Exam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected meniscal injuries to the knee&#xD;
&#xD;
          -  Suspected articular cartilage injuries to the knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute traumatic hemarthroses and/or concomitant ligament injury&#xD;
&#xD;
          -  Active systemic infection&#xD;
&#xD;
          -  Allergy to silicone or any medication used during the procedure&#xD;
&#xD;
          -  Enrollment in another pharmacological or medical device study&#xD;
&#xD;
          -  Institutionalized persons, prisoners and persons with decisional incapacity&#xD;
&#xD;
          -  Investigator's own students and employees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas J Gill, IV, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kerlan-Jobe Orthopaedic Foundation</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford School of Medicine</name>
      <address>
        <city>Redwood</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica Orthopaedic &amp; Sports Medicine Group (SMOG)</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Research and Education Institute</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas SouthWestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mansfield Orthopaedics (Copley Hospital)</name>
      <address>
        <city>Morrisville</city>
        <state>Vermont</state>
        <zip>05661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rheumatology 2000; 39: 700-706, British Society for Rheumatology</citation>
  </reference>
  <reference>
    <citation>Ryzewicz M, Peterson B, Siparsky PN, Bartz RL. The diagnosis of meniscus tears: the role of MRI and clinical examination. Clin Orthop Relat Res. 2007 Feb;455:123-33. doi: 10.1097/BLO.0b013e31802fb9f3.</citation>
    <PMID>17279041</PMID>
  </reference>
  <reference>
    <citation>Ruwe PA, McCarthy SM. Cost effectiveness of magnetic resonance imaging of the knee. Magn Reson Imaging Clin N Am. 1994 Aug;2(3):475-9.</citation>
    <PMID>7489301</PMID>
  </reference>
  <reference>
    <citation>Rappeport ED, Wieslander SB, Stephensen S, Lausten GS, Thomsen HS. MRI preferable to diagnostic arthroscopy in knee joint injuries. A double-blind comparison of 47 patients. Acta Orthop Scand. 1997 Jun;68(3):277-81. doi: 10.3109/17453679708996701.</citation>
    <PMID>9246993</PMID>
  </reference>
  <reference>
    <citation>Rangger C, Klestil T, Kathrein A, Inderster A, Hamid L. Influence of magnetic resonance imaging on indications for arthroscopy of the knee. Clin Orthop Relat Res. 1996 Sep;(330):133-42. doi: 10.1097/00003086-199609000-00016.</citation>
    <PMID>8804283</PMID>
  </reference>
  <reference>
    <citation>De Smet AA, Mukherjee R. Clinical, MRI, and arthroscopic findings associated with failure to diagnose a lateral meniscal tear on knee MRI. AJR Am J Roentgenol. 2008 Jan;190(1):22-6. doi: 10.2214/AJR.07.2611.</citation>
    <PMID>18094289</PMID>
  </reference>
  <reference>
    <citation>Halinen J, Koivikko M, Lindahl J, Hirvensalo E. The efficacy of magnetic resonance imaging in acute multi-ligament injuries. Int Orthop. 2009 Dec;33(6):1733-8. doi: 10.1007/s00264-008-0689-6. Epub 2008 Dec 3.</citation>
    <PMID>19050885</PMID>
  </reference>
  <reference>
    <citation>Mandelbaum BR, Finerman GA, Reicher MA, Hartzman S, Bassett LW, Gold RH, Rauschning W, Dorey F. Magnetic resonance imaging as a tool for evaluation of traumatic knee injuries. Anatomical and pathoanatomical correlations. Am J Sports Med. 1986 Sep-Oct;14(5):361-70. doi: 10.1177/036354658601400503.</citation>
    <PMID>3535549</PMID>
  </reference>
  <reference>
    <citation>Rayan F, Bhonsle S, Shukla DD. Clinical, MRI, and arthroscopic correlation in meniscal and anterior cruciate ligament injuries. Int Orthop. 2009 Feb;33(1):129-32. doi: 10.1007/s00264-008-0520-4. Epub 2008 Feb 23.</citation>
    <PMID>18297284</PMID>
  </reference>
  <reference>
    <citation>von Engelhardt LV, Lahner M, Klussmann A, Bouillon B, David A, Haage P, Lichtinger TK. Arthroscopy vs. MRI for a detailed assessment of cartilage disease in osteoarthritis: diagnostic value of MRI in clinical practice. BMC Musculoskelet Disord. 2010 Apr 20;11:75. doi: 10.1186/1471-2474-11-75.</citation>
    <PMID>20406481</PMID>
  </reference>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>May 29, 2013</last_update_submitted>
  <last_update_submitted_qc>May 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee Injuries</keyword>
  <keyword>Meniscus Injuries</keyword>
  <keyword>Articular Cartilage Injuries</keyword>
  <keyword>Orthopaedic Diagnostic</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01695720
org study id: VisionScope VSI-001
nct id: NCT01695720
lead sponsor: 
has dmc: No
The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for
      pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).
      The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.

      The hypothesis is the VisionScope Imaging system will be able to provide direct visualization
      and diagnostic images of inside the joint capsule space without fluid distention in the knee.
      This study will provide valuable feedback on the ability of the VisionScope system to provide
      physicians with the information they need to make a definitive diagnosis.
The primary objective of this study is to accumulate efficacy data on the VisionScope Imaging
      System (VSI) for pre-operative diagnoses when it is used to provide illumination and
      visualization of articular cavities. The study will analyze the VisionScope system's accuracy
      compared to MRI in diagnosing and confirming meniscus tears, chondral defects, loose bodies,
      minor arthritis, and/or any articular or capsular trauma.

      The hypothesis of the study is that the VisionScope System will be able to obtain direct
      visualization and diagnostic images of the intercapsular space without fluid distention in
      the knee. This study will provide feedback on the ability of the VisionScope system to
      potentially eliminate the need for MRI scans. Additionally, a cost-analysis comparison
      between the use of VSI vs. MRI for the diagnosis of orthopaedic knee injuries will be
      conducted. Finally, the study will help develop an algorithm of potential use for the VSI
      system in the management of knee pathologies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic Accuracy
time frame: 1 day
description: Diagnostic accuracy will be assessed during the time of the procedure. There will be no patient followup in this study. Radiologists, post procedure, will compare/contrast the diagnostic findings of a patient's MRI, VSI and Dx Arthroscopy.
arm group label: VisionScope Imaging (VSI) Exam
arm group type: Experimental
description: A VisionScope Imaging (VSI) Exam is diagnostic arthroscopic procedure. Through a natural or surgical opening, an endoscope is inserted through a cannula to illuminate and visualize the interior cavity of a joint.
intervention type: Procedure
intervention name: VisionScope Imaging (VSI) Exam
description: The VisionScope Imaging (VSI) Exam [the system itself] is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening.
arm group label: VisionScope Imaging (VSI) Exam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Thomas J Gill, IV, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Rheumatology 2000; 39: 700-706, British Society for Rheumatology
citation: Ryzewicz M, Peterson B, Siparsky PN, Bartz RL. The diagnosis of meniscus tears: the role of MRI and clinical examination. Clin Orthop Relat Res. 2007 Feb;455:123-33. doi: 10.1097/BLO.0b013e31802fb9f3.
PMID: 17279041
citation: Ruwe PA, McCarthy SM. Cost effectiveness of magnetic resonance imaging of the knee. Magn Reson Imaging Clin N Am. 1994 Aug;2(3):475-9.
PMID: 7489301
citation: Rappeport ED, Wieslander SB, Stephensen S, Lausten GS, Thomsen HS. MRI preferable to diagnostic arthroscopy in knee joint injuries. A double-blind comparison of 47 patients. Acta Orthop Scand. 1997 Jun;68(3):277-81. doi: 10.3109/17453679708996701.
PMID: 9246993
citation: Rangger C, Klestil T, Kathrein A, Inderster A, Hamid L. Influence of magnetic resonance imaging on indications for arthroscopy of the knee. Clin Orthop Relat Res. 1996 Sep;(330):133-42. doi: 10.1097/00003086-199609000-00016.
PMID: 8804283
citation: De Smet AA, Mukherjee R. Clinical, MRI, and arthroscopic findings associated with failure to diagnose a lateral meniscal tear on knee MRI. AJR Am J Roentgenol. 2008 Jan;190(1):22-6. doi: 10.2214/AJR.07.2611.
PMID: 18094289
citation: Halinen J, Koivikko M, Lindahl J, Hirvensalo E. The efficacy of magnetic resonance imaging in acute multi-ligament injuries. Int Orthop. 2009 Dec;33(6):1733-8. doi: 10.1007/s00264-008-0689-6. Epub 2008 Dec 3.
PMID: 19050885
citation: Mandelbaum BR, Finerman GA, Reicher MA, Hartzman S, Bassett LW, Gold RH, Rauschning W, Dorey F. Magnetic resonance imaging as a tool for evaluation of traumatic knee injuries. Anatomical and pathoanatomical correlations. Am J Sports Med. 1986 Sep-Oct;14(5):361-70. doi: 10.1177/036354658601400503.
PMID: 3535549
citation: Rayan F, Bhonsle S, Shukla DD. Clinical, MRI, and arthroscopic correlation in meniscal and anterior cruciate ligament injuries. Int Orthop. 2009 Feb;33(1):129-32. doi: 10.1007/s00264-008-0520-4. Epub 2008 Feb 23.
PMID: 18297284
citation: von Engelhardt LV, Lahner M, Klussmann A, Bouillon B, David A, Haage P, Lichtinger TK. Arthroscopy vs. MRI for a detailed assessment of cartilage disease in osteoarthritis: diagnostic value of MRI in clinical practice. BMC Musculoskelet Disord. 2010 Apr 20;11:75. doi: 10.1186/1471-2474-11-75.
PMID: 20406481
responsible party type: Sponsor
mesh term: Osteoarthritis