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/NCT06020508</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0074</org_study_id>
      <nct_id>NCT06020508</nct_id>
    </id_info>
    <brief_title>Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement</brief_title>
    <official_title>Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital for Special Surgery, New York</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Lumoptik</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital for Special Surgery, New York</source>
    <oversight_info>
      <has_dmc>Yes</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test the BrightPoint Epidural device as the first&#xD;
        system to use multispectral reflectometry to find the epidural space in lumbar neuraxial&#xD;
        procedures requiring epidural needle. The main questions it aims to answer are:&#xD;
  &#xD;
          1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?&#xD;
  &#xD;
          2. Is the device a qualitatively effective training tool for educating trainees in how to&#xD;
             perform lumbar epidurals?&#xD;
  &#xD;
        Participants will undergo a neuraxial procedure in which the attending anesthesiologist will&#xD;
        use the BrightPoint epidural device to form an opinion on its effectiveness in confirming&#xD;
        epidural space access.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There have been few improvements to the LOR technique from a device standpoint in recent&#xD;
        years, and those that options do exist have not achieved widespread clinical use. The devices&#xD;
        that do exist are variations on pressure sensors, some automate the &quot;resistance&quot; by placing&#xD;
        various systems in place to apply a pressure to the plunger so that it will inject when the&#xD;
        epidural space is accessed without the practitioner doing it themselves. This concept is&#xD;
        represented by devices such as the Epimatic syringe from Vygon. Others improve on this&#xD;
        concept by monitoring the pressure required to inject a set volume of fluid, thus being able&#xD;
        to differentiate between true and false losses, as during false losses the pressure will&#xD;
        increase as more fluid is injected. This system is represented by the CompuFlo Device by&#xD;
        Milestone Scientific.&#xD;
  &#xD;
        The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry&#xD;
        in order to identify the epidural space. This technology has the theoretical benefit over&#xD;
        pressure-based systems of being able to identify and differentiate between different issue&#xD;
        types (muscle, ligament, bone) as the needle is advanced towards the epidural space.&#xD;
        Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based&#xD;
        in Cleveland, Ohio. The main questions this trial aims to answer are:&#xD;
  &#xD;
          1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?&#xD;
  &#xD;
          2. Is the device a qualitatively effective training tool for educating trainees in how to&#xD;
             perform lumbar epidurals?&#xD;
  &#xD;
        This trial is being conducted to improve our current standard of care in neuraxial placement&#xD;
        of loss-of-resistance. While the loss of resistance technique is tried and true, especially&#xD;
        in experienced hands, complications such as dural punctures, misplaced epidurals, patchy&#xD;
        epidurals, neurologic injuries, and intravascular catheters can occur even in experienced&#xD;
        hands. All of which can cause significant patient morbidity and costs to the healthcare&#xD;
        system, and as is shown in the Lacombe attached, the effects of dural puncture can be long&#xD;
        lived for the patient. There can also be a steep learning curve when learning the technique,&#xD;
        with the frequency of inadvertent dural punctures significantly higher in the early stages of&#xD;
        learning the procedure. Therefore, we as a specialty are obligated to evaluate potential&#xD;
        improvements to our current way of practice to reduce the burden to our patients from the&#xD;
        complications of our interventions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Real time confirmation of epidural space with loss of resistance technique</measure>
      <time_frame>Post-operation (after the surgery is complete)</time_frame>
      <description>On the post-procedure questionnaire, the anesthesiologist will report about whether the device identified epidural space in agreement with loss of resistance technique.&#xD;
  If no, the outcome will be recorded as either a false positive (device signaled epidural space while needle was not in epidural space) or false negative (device did not signal epidural space while needle was in epidural space).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device</measure>
      <time_frame>Post-operation (after the surgery is complete)</time_frame>
      <description>On the post-procedure questionnaire, the anesthesiologist will give their opinion about the device following their use of the study device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Color graphics aid in the identification of needle tips.</measure>
      <time_frame>Post-operation (after the surgery is complete)</time_frame>
      <description>On the post-procedure questionnaire, the proceduralist will give a yes or no answer to the prompt to the question &quot;Did the Bright Point Epidural color graphic improve your understanding of where your needle tip is or what tissue it is in?&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time it takes to insert the epidural needle into the patient's skin.</measure>
      <time_frame>From &quot;in OR time&quot; to &quot;time when needle is inserted&quot;</time_frame>
      <description>The time between when the patient entered the operating room and when the epidural needle was inserted into the patient's skin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time it takes to successfully identify the epidural space.</measure>
      <time_frame>From &quot;time when needle is inserted&quot; to &quot;time when epidural space is identified&quot;</time_frame>
      <description>The time between inserting an epidural needle into the skin and successfully identifying the epidural space.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of Successful Neuraxial Procedures</measure>
      <time_frame>Post-operation (after the surgery is complete)</time_frame>
      <description>The percentage of successful neuraxial procedures, calculated by dividing &quot;the number successful neuraxial procedures placed without assistance or complication by the number of attempted neuraxial procedures&quot;</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Lumbar Spine Surgery</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Attending anesthesiologists who are trained in epidural placement will perform neuraxial procedures (CSEs, Epidural, Spinals through an epidural needle) utilizing loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device. The Lumoptik device will be connected between a standard commercially available 17G or 18G, 3.5-inch epidural needle and a saline filled loss of resistance syringe. The anesthesiologist will view the Lumoptik BrightPoint visual display in real time as the epidural procedures are performed. The LOR epidural procedure using haptic feedback will be used as the primary confirmation of correct needle placement in the epidural space. Graphic and color circle information from the Lumoptik visual display will be used as a secondary confirmation of epidural placement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group 1 - Lumoptik BrightPoint Epidural Device</intervention_name>
      <description>Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients scheduled to have surgery at the Hospital for Special Surgery that will require a&#xD;
          lumbar neuraxial procedure requiring an epidural needle.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any patient undergoing a lumbar neuraxial procedure requiring epidural needle&#xD;
  &#xD;
            -  Age 18-99&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous lumbar spine surgery&#xD;
  &#xD;
            -  Any known spinal abnormality that would interfere with successfully advancing a needle&#xD;
               into the epidural space&#xD;
  &#xD;
            -  Any patient requiring epidural needle longer than 4 inches&#xD;
  &#xD;
            -  Any contraindication to neuraxial anesthesia&#xD;
  &#xD;
            -  Tattoo at the site of epidural insertion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Singleton, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital for Special Surgery, New York</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Justas Lauzadis, PhD</last_name>
      <phone>212-774-2946</phone>
      <email>lauzadisj@hss.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pa Thor, PhD</last_name>
      <phone>646-797-8535</phone>
      <email>thorp@hss.edu</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Lacombe A, Downey K, Ye XY, Carvalho JCA. Long-term complications of unintentional dural puncture during labor epidural analgesia: a case-control study. Reg Anesth Pain Med. 2022 Jun;47(6):364-369. doi: 10.1136/rapm-2021-103266. Epub 2022 Mar 25.</citation>
      <PMID>35338103</PMID>
    </results_reference>
    <results_reference>
      <citation>Eley VA, Abeypala W, Kelley A, Kumta N, Chin A. Recognized and unrecognized dural punctures in 12,981 labor epidurals: an audit of management. J Anesth. 2022 Jun;36(3):399-404. doi: 10.1007/s00540-022-03062-7. Epub 2022 Apr 27.</citation>
      <PMID>35474399</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>epidural</keyword>
    <keyword>neuraxial</keyword>
    <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/NCT06020508
  org study id: 2023-0074
  nct id: NCT06020508
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this clinical trial is to test the BrightPoint Epidural device as the first
        system to use multispectral reflectometry to find the epidural space in lumbar neuraxial
        procedures requiring epidural needle. The main questions it aims to answer are:
  
          1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
  
          2. Is the device a qualitatively effective training tool for educating trainees in how to
             perform lumbar epidurals?
  
        Participants will undergo a neuraxial procedure in which the attending anesthesiologist will
        use the BrightPoint epidural device to form an opinion on its effectiveness in confirming
        epidural space access.
  There have been few improvements to the LOR technique from a device standpoint in recent
        years, and those that options do exist have not achieved widespread clinical use. The devices
        that do exist are variations on pressure sensors, some automate the "resistance" by placing
        various systems in place to apply a pressure to the plunger so that it will inject when the
        epidural space is accessed without the practitioner doing it themselves. This concept is
        represented by devices such as the Epimatic syringe from Vygon. Others improve on this
        concept by monitoring the pressure required to inject a set volume of fluid, thus being able
        to differentiate between true and false losses, as during false losses the pressure will
        increase as more fluid is injected. This system is represented by the CompuFlo Device by
        Milestone Scientific.
  
        The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry
        in order to identify the epidural space. This technology has the theoretical benefit over
        pressure-based systems of being able to identify and differentiate between different issue
        types (muscle, ligament, bone) as the needle is advanced towards the epidural space.
        Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based
        in Cleveland, Ohio. The main questions this trial aims to answer are:
  
          1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
  
          2. Is the device a qualitatively effective training tool for educating trainees in how to
             perform lumbar epidurals?
  
        This trial is being conducted to improve our current standard of care in neuraxial placement
        of loss-of-resistance. While the loss of resistance technique is tried and true, especially
        in experienced hands, complications such as dural punctures, misplaced epidurals, patchy
        epidurals, neurologic injuries, and intravascular catheters can occur even in experienced
        hands. All of which can cause significant patient morbidity and costs to the healthcare
        system, and as is shown in the Lacombe attached, the effects of dural puncture can be long
        lived for the patient. There can also be a steep learning curve when learning the technique,
        with the frequency of inadvertent dural punctures significantly higher in the early stages of
        learning the procedure. Therefore, we as a specialty are obligated to evaluate potential
        improvements to our current way of practice to reduce the burden to our patients from the
        complications of our interventions.
  observational model: Other
  time perspective: Prospective
  measure: Real time confirmation of epidural space with loss of resistance technique
  time frame: Post-operation (after the surgery is complete)
  description: On the post-procedure questionnaire, the anesthesiologist will report about whether the device identified epidural space in agreement with loss of resistance technique.
  If no, the outcome will be recorded as either a false positive (device signaled epidural space while needle was not in epidural space) or false negative (device did not signal epidural space while needle was in epidural space).
  measure: Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device
  time frame: Post-operation (after the surgery is complete)
  description: On the post-procedure questionnaire, the anesthesiologist will give their opinion about the device following their use of the study device.
  measure: Color graphics aid in the identification of needle tips.
  time frame: Post-operation (after the surgery is complete)
  description: On the post-procedure questionnaire, the proceduralist will give a yes or no answer to the prompt to the question "Did the Bright Point Epidural color graphic improve your understanding of where your needle tip is or what tissue it is in?"
  measure: The time it takes to insert the epidural needle into the patient's skin.
  time frame: From "in OR time" to "time when needle is inserted"
  description: The time between when the patient entered the operating room and when the epidural needle was inserted into the patient's skin.
  measure: The time it takes to successfully identify the epidural space.
  time frame: From "time when needle is inserted" to "time when epidural space is identified"
  description: The time between inserting an epidural needle into the skin and successfully identifying the epidural space.
  measure: The percentage of Successful Neuraxial Procedures
  time frame: Post-operation (after the surgery is complete)
  description: The percentage of successful neuraxial procedures, calculated by dividing "the number successful neuraxial procedures placed without assistance or complication by the number of attempted neuraxial procedures"
  arm group label: Group 1
  description: Attending anesthesiologists who are trained in epidural placement will perform neuraxial procedures (CSEs, Epidural, Spinals through an epidural needle) utilizing loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device. The Lumoptik device will be connected between a standard commercially available 17G or 18G, 3.5-inch epidural needle and a saline filled loss of resistance syringe. The anesthesiologist will view the Lumoptik BrightPoint visual display in real time as the epidural procedures are performed. The LOR epidural procedure using haptic feedback will be used as the primary confirmation of correct needle placement in the epidural space. Graphic and color circle information from the Lumoptik visual display will be used as a secondary confirmation of epidural placement.
  intervention type: Device
  intervention name: Group 1 - Lumoptik BrightPoint Epidural Device
  description: Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.
  arm group label: Group 1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michael Singleton, MD
  role: Principal Investigator
  affiliation: Hospital for Special Surgery, New York
  last name: Justas Lauzadis, PhD
  phone: 212-774-2946
  email: lauzadisj@hss.edu
  last name: Pa Thor, PhD
  phone: 646-797-8535
  email: thorp@hss.edu
  citation: Lacombe A, Downey K, Ye XY, Carvalho JCA. Long-term complications of unintentional dural puncture during labor epidural analgesia: a case-control study. Reg Anesth Pain Med. 2022 Jun;47(6):364-369. doi: 10.1136/rapm-2021-103266. Epub 2022 Mar 25.
  PMID: 35338103
  citation: Eley VA, Abeypala W, Kelley A, Kumta N, Chin A. Recognized and unrecognized dural punctures in 12,981 labor epidurals: an audit of management. J Anesth. 2022 Jun;36(3):399-404. doi: 10.1007/s00540-022-03062-7. Epub 2022 Apr 27.
  PMID: 35474399
  responsible party type: Sponsor
  sharing ipd: No