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/NCT06020573</url>
    </required_header>
    <id_info>
      <org_study_id>2020-02</org_study_id>
      <nct_id>NCT06020573</nct_id>
    </id_info>
    <brief_title>Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection</brief_title>
    <official_title>Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erbe Elektromedizin GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erbe Elektromedizin GmbH</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>
        This monocentric early feasibility first in human study is intended to evaluate safety and&#xD;
        performance of intraoperative detection of light signals during electrosurgical breast cancer&#xD;
        resection.&#xD;
  &#xD;
        In consequence the data should also be taken to adapt technical features according to the&#xD;
        findings. The study results will be utilized to design and to calculate the sample size for&#xD;
        future pivotal studies after finalizing this study and to adapt the technical features of the&#xD;
        system and/ or device. In the future pivotal study, the effectiveness of method and the&#xD;
        reduction in R1 resection rate will be assessed with the final goal to provide continuous or&#xD;
        real-time information about the tissue type that is currently cut.&#xD;
  &#xD;
        The primary endpoint for this first in human feasibility study is the percentage of patients&#xD;
        with no serious adverse event related to the investigational device.&#xD;
  &#xD;
        After signing the informed consent the doctor and research team will determine if the&#xD;
        participant meets all requirements for this study. During the second visit (V2) they will&#xD;
        receive the treatment procedure with the investigational medical device (IMD). The follow up&#xD;
        visit (V3) will be performed up to 7 days after the treatment procedure at the day of&#xD;
        discharge from the hospital.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 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>Safety, feasibility and performance</measure>
      <time_frame>11 days</time_frame>
      <description>The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Resection Margin</condition>
    <arm_group>
      <arm_group_label>Intraoperative detection of light signals during electrosurgical breast cancer resection</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Clip-on electrode with fiber optics</intervention_name>
      <description>The device will be used for tumor resection of breast cancer and for the collection of optical data that could be ultimately used for providing additional information.</description>
      <arm_group_label>Intraoperative detection of light signals during electrosurgical breast cancer resection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Female patient with primary invasive breast cancer (NST or NST with DCIS component,&#xD;
               including endocrine pretreatment according to standard of care therapy at the study&#xD;
               site)&#xD;
  &#xD;
            2. Solid tumor size ≥ 15 mm at screening, on sonography imaging&#xD;
  &#xD;
            3. Breast conserving surgery&#xD;
  &#xD;
            4. ≥ 18 years of age&#xD;
  &#xD;
            5. Ability to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Neoadjuvant chemotherapy&#xD;
  &#xD;
            2. Bilateral breast conserving surgery&#xD;
  &#xD;
            3. Invasive lobular carcinoma, DCIS, LCIS&#xD;
  &#xD;
            4. Suspicion of extensive DCIS component of NST tumor&#xD;
  &#xD;
            5. Diagnosis of recurrent breast cancer&#xD;
  &#xD;
            6. Previous radiotherapy&#xD;
  &#xD;
            7. Patient is pregnant or lactating&#xD;
  &#xD;
            8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other&#xD;
               active implant), passive implants (hip arthroplasties, tooth implants etc.) are&#xD;
               allowed at the discretion of the principal investigator&#xD;
  &#xD;
            9. According to physicians' assessment, patient is not able to follow study protocol&#xD;
               (e.g., due to cognitive disease) or is not able to understand the nature, objectives,&#xD;
               benefits, implications, risks and inconveniences of the clinical investigation&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Markus Hahn, Prof.Dr. Med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department for Women's Health, Tuebingen, Germany</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vanessa Hartmann</last_name>
      <phone>+4970717552850</phone>
      <email>vanessa.hartmann@erbe-med.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gabriela Soares</last_name>
      <phone>+4970717552976</phone>
      <email>gabriela.soares@erbe-med.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department for Women's Health</name>
        <address>
          <city>Tuebingen</city>
          <zip>72076</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Markus Hahn, Prof. Dr. med</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <reference>
      <citation>Spether D, Scharpf M, Hennenlotter J, Schwentner C, Neugebauer A, Nussle D, Fischer K, Zappe H, Stenzl A, Fend F, Seifert A, Enderle M. Real-time tissue differentiation based on optical emission spectroscopy for guided electrosurgical tumor resection. Biomed Opt Express. 2015 Mar 24;6(4):1419-28. doi: 10.1364/BOE.6.001419. eCollection 2015 Apr 1.</citation>
      <PMID>25909025</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06020573
  org study id: 2020-02
  nct id: NCT06020573
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This monocentric early feasibility first in human study is intended to evaluate safety and
        performance of intraoperative detection of light signals during electrosurgical breast cancer
        resection.
  
        In consequence the data should also be taken to adapt technical features according to the
        findings. The study results will be utilized to design and to calculate the sample size for
        future pivotal studies after finalizing this study and to adapt the technical features of the
        system and/ or device. In the future pivotal study, the effectiveness of method and the
        reduction in R1 resection rate will be assessed with the final goal to provide continuous or
        real-time information about the tissue type that is currently cut.
  
        The primary endpoint for this first in human feasibility study is the percentage of patients
        with no serious adverse event related to the investigational device.
  
        After signing the informed consent the doctor and research team will determine if the
        participant meets all requirements for this study. During the second visit (V2) they will
        receive the treatment procedure with the investigational medical device (IMD). The follow up
        visit (V3) will be performed up to 7 days after the treatment procedure at the day of
        discharge from the hospital.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety, feasibility and performance
  time frame: 11 days
  description: The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.
  arm group label: Intraoperative detection of light signals during electrosurgical breast cancer resection
  arm group type: Other
  description: Participants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively
  intervention type: Device
  intervention name: Clip-on electrode with fiber optics
  description: The device will be used for tumor resection of breast cancer and for the collection of optical data that could be ultimately used for providing additional information.
  arm group label: Intraoperative detection of light signals during electrosurgical breast cancer resection
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Markus Hahn, Prof.Dr. Med.
  role: Principal Investigator
  affiliation: Department for Women's Health, Tuebingen, Germany
  last name: Vanessa Hartmann
  phone: +4970717552850
  email: vanessa.hartmann@erbe-med.com
  last name: Gabriela Soares
  phone: +4970717552976
  email: gabriela.soares@erbe-med.com
  facility: 
  contact: 
  country: Germany
  citation: Spether D, Scharpf M, Hennenlotter J, Schwentner C, Neugebauer A, Nussle D, Fischer K, Zappe H, Stenzl A, Fend F, Seifert A, Enderle M. Real-time tissue differentiation based on optical emission spectroscopy for guided electrosurgical tumor resection. Biomed Opt Express. 2015 Mar 24;6(4):1419-28. doi: 10.1364/BOE.6.001419. eCollection 2015 Apr 1.
  PMID: 25909025
  responsible party type: Sponsor
  mesh term: Breast Neoplasms