<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/NCT03015649</url>
  </required_header>
  <id_info>
    <org_study_id>CMI-SCOUT-001</org_study_id>
    <nct_id>NCT03015649</nct_id>
  </id_info>
  <brief_title>Long Term Use of SAVI SCOUT: Pilot Study</brief_title>
  <official_title>Evaluation of Longer Duration Use of the SAVI SCOUT Surgical Guidance System for Excision of Breast and Axillary Lesions in Neo-adjuvant Therapy Patients: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Envision Healthcare Scientific Intelligence, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cianna Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Envision Healthcare Scientific Intelligence, Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast&#xD;
      Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery.&#xD;
      The device is a non-wire system, which uses nonradioactive light-activated radar, to provide&#xD;
      breast surgeons with real-time guidance to locate and remove the target lesion in the breast&#xD;
      and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days&#xD;
      prior to surgery to assist surgeons in the localization and retrieval of breast/axillary&#xD;
      lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this&#xD;
      study, investigators will assess the longer term placement of the SCOUT device over an&#xD;
      extended time (31 - 365 days) in order to address the needs of patients who require&#xD;
      neoadjuvant treatment prior to definitive surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SAVI SCOUT (Cianna Medical, Inc.) surgical guidance system received 510(k) U.S. Food and&#xD;
      Drug Administration (FDA) approval in August 2014. This system is used as a standard of care&#xD;
      since 2015 in the Memorial Healthcare System (MHS) operating rooms by experienced breast&#xD;
      surgeons (over 150 MHS breast cancer patients and over 5,000 U.S. breast cancer patients as&#xD;
      of September 2016). In MHS standard of care practice, the device is placed at the target&#xD;
      lesion(s) under image-guidance by the radiologist up to 30 days prior to surgery.&#xD;
&#xD;
      Patients with certain types of breast cancer undergo neoadjuvant treatment with biologic&#xD;
      (hormonal) and/or chemotherapy with the goal of decreasing the tumor volume prior to&#xD;
      definitive surgery. If the original cancer lesion(s) resolve completely, this is called&#xD;
      complete pathologic response (pCR). pCR and even a partial response, while good for the&#xD;
      patient, can result in disappearance or poor visualization of the target and often render&#xD;
      pre-operative image-guided localization by the radiologist more difficult and less reliable.&#xD;
      This can result in unintended larger, more disfiguring breast cancer surgery. Therefore, if&#xD;
      the SCOUT device can be placed prior to treatment response, when the lesion is clearly&#xD;
      visualized on imaging, accurate image-guided targeting is optimal and thus placement and&#xD;
      subsequent surgery should be more accurate. If this pilot study demonstrates successful&#xD;
      performance of the device without device-related complications, it will bring improved value&#xD;
      to future patients who will require fewer and/or less extensive pre-operative and surgical&#xD;
      procedures. Some value may also be provided to subjects as the targeting before tumor&#xD;
      shrinkage is expected to be more accurate.&#xD;
&#xD;
      Thus, this pilot study will assess the performance of FDA-cleared SCOUT system over a longer&#xD;
      duration prior to breast and/or axillary lymph node surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">April 4, 2019</completion_date>
  <primary_completion_date type="Actual">September 10, 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Considered to Have a Successful Surgery</measure>
    <time_frame>31 - 365 days prior to surgery</time_frame>
    <description>The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Breast Diseases</condition>
  <arm_group>
    <arm_group_label>SCOUT device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study population consists of 25 - 35 adult surgical patient volunteers who plan to have definitive breast cancer surgery at Memorial Healthcare System (MHS) Hospitals after neoadjuvant treatment.&#xD;
The investigator will identify subjects who meet inclusion/exclusion criteria, obtain patient's consent and schedule the subject for the SAVI SCOUT Surgical Guidance System procedure. All study participants will receive the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Neoadjuvant treatment decisions will be determined by patient's medical oncologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SAVI SCOUT Surgical Guidance System</intervention_name>
    <description>SAVI SCOUT Surgical Guidance System is a non-wire system, which uses nonradioactive light-activated radar, to provide breast surgeons with real-time guidance to locate and remove the target lesion in the breast and/or axillary tissue.</description>
    <arm_group_label>SCOUT device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is willing and able to provide informed consent. Patient SCOUT device(s) is&#xD;
             placed as part of routine care or study but before neoadjuvant treatment begins.&#xD;
&#xD;
          -  Patient is female.&#xD;
&#xD;
          -  Patient is between the ages of 18 and 90 years.&#xD;
&#xD;
          -  Patient has breast cancer and will undergo neoadjuvant therapy and excision at&#xD;
             Memorial Healthcare System.&#xD;
&#xD;
          -  Patient is willing and able to comply with all study procedures and be available to&#xD;
             follow-up for the duration of the study (1 - 13 months).&#xD;
&#xD;
          -  Patient reads or understands English or Spanish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant.&#xD;
&#xD;
          -  Patient has pacemaker or implantable defibrillators (These have not been bench tested&#xD;
             as of September 2016).&#xD;
&#xD;
          -  Patient has known or suspected nickel allergy.&#xD;
&#xD;
          -  Patient is scheduled or receiving investigational drugs for neoadjuvant regimen. (This&#xD;
             could confound UADE of this device.)&#xD;
&#xD;
          -  Patient has any condition that would place the individual at increased risk or&#xD;
             preclude the individual's full compliance with or completion of the study.&#xD;
&#xD;
          -  Patient has other malignancy except for adequately treated and cured basal or squamous&#xD;
             cancer, curatively treated in situ disease or any other cancer for which the patient&#xD;
             has been disease free for greater than or equal to 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Hayes-Macaluso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Envision Healthcare Scientific Intelligence, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Envision Physician Scientific Research, Inc. formerly Sheridan Healthcare, Inc.</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cox CE, Garcia-Henriquez N, Glancy MJ, Whitworth P, Cox JM, Themar-Geck M, Prati R, Jung M, Russell S, Appleton K, King J, Shivers SC. Pilot Study of a New Nonradioactive Surgical Guidance Technology for Locating Nonpalpable Breast Lesions. Ann Surg Oncol. 2016 Jun;23(6):1824-30. doi: 10.1245/s10434-015-5079-x. Epub 2016 Feb 3.</citation>
    <PMID>26847680</PMID>
  </reference>
  <reference>
    <citation>Caudle AS, Yang WT, Mittendorf EA, Black DM, Hwang R, Hobbs B, Hunt KK, Krishnamurthy S, Kuerer HM. Selective surgical localization of axillary lymph nodes containing metastases in patients with breast cancer: a prospective feasibility trial. JAMA Surg. 2015 Feb;150(2):137-43. doi: 10.1001/jamasurg.2014.1086.</citation>
    <PMID>25517573</PMID>
  </reference>
  <reference>
    <citation>Hylton NM, Gatsonis CA, Rosen MA, Lehman CD, Newitt DC, Partridge SC, Bernreuter WK, Pisano ED, Morris EA, Weatherall PT, Polin SM, Newstead GM, Marques HS, Esserman LJ, Schnall MD; ACRIN 6657 Trial Team and I-SPY 1 TRIAL Investigators. Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival-Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL. Radiology. 2016 Apr;279(1):44-55. doi: 10.1148/radiol.2015150013. Epub 2015 Dec 1.</citation>
    <PMID>26624971</PMID>
  </reference>
  <reference>
    <citation>Mango V, Ha R, Gomberawalla A, Wynn R, Feldman S. Evaluation of the SAVI SCOUT Surgical Guidance System for Localization and Excision of Nonpalpable Breast Lesions: A Feasibility Study. AJR Am J Roentgenol. 2016 Oct;207(4):W69-W72. doi: 10.2214/AJR.15.15962. Epub 2016 Jun 15.</citation>
    <PMID>27304083</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>April 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2020</results_first_posted>
  <last_update_submitted>April 30, 2020</last_update_submitted>
  <last_update_submitted_qc>April 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>neoadjuvant treatment</keyword>
  <keyword>surgical guidance system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03015649/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03015649/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SCOUT Device</title>
          <description>All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SCOUT Device</title>
          <description>All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" lower_limit="28" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Node Positive</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Considered to Have a Successful Surgery</title>
        <description>The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.</description>
        <time_frame>31 - 365 days prior to surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SCOUT Device</title>
            <description>All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Considered to Have a Successful Surgery</title>
          <description>The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0 months - 14 months. Reportable adverse events were collected from the time after informed consent is obtained until 30 days (for non-serious AEs) or 7 days (for SAEs) after the last day of study participation</time_frame>
      <desc>Adverse events from underlying diseases and related to neoadjuvant treatments were not intended to be collected. The written Protocol was amended to clarify this point. All reported SAEs were unrelated to the investigational device and collected prior to the Protocol amendment. The collected events were all previously known as anticipated side effects of chemotherapy and fertility preservation.</desc>
      <group_list>
        <group group_id="E1">
          <title>SCOUT Device</title>
          <description>All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Principal Investigator has left the organization.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Women's Imaging Director</name_or_title>
      <organization>Envision Healthcare Scientific Intelligence, Inc.</organization>
      <phone>9549397729</phone>
      <email>clinicaltrials@shcr.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03015649
org study id: CMI-SCOUT-001
nct id: NCT03015649
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast
      Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery.
      The device is a non-wire system, which uses nonradioactive light-activated radar, to provide
      breast surgeons with real-time guidance to locate and remove the target lesion in the breast
      and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days
      prior to surgery to assist surgeons in the localization and retrieval of breast/axillary
      lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this
      study, investigators will assess the longer term placement of the SCOUT device over an
      extended time (31 - 365 days) in order to address the needs of patients who require
      neoadjuvant treatment prior to definitive surgery.
The SAVI SCOUT (Cianna Medical, Inc.) surgical guidance system received 510(k) U.S. Food and
      Drug Administration (FDA) approval in August 2014. This system is used as a standard of care
      since 2015 in the Memorial Healthcare System (MHS) operating rooms by experienced breast
      surgeons (over 150 MHS breast cancer patients and over 5,000 U.S. breast cancer patients as
      of September 2016). In MHS standard of care practice, the device is placed at the target
      lesion(s) under image-guidance by the radiologist up to 30 days prior to surgery.

      Patients with certain types of breast cancer undergo neoadjuvant treatment with biologic
      (hormonal) and/or chemotherapy with the goal of decreasing the tumor volume prior to
      definitive surgery. If the original cancer lesion(s) resolve completely, this is called
      complete pathologic response (pCR). pCR and even a partial response, while good for the
      patient, can result in disappearance or poor visualization of the target and often render
      pre-operative image-guided localization by the radiologist more difficult and less reliable.
      This can result in unintended larger, more disfiguring breast cancer surgery. Therefore, if
      the SCOUT device can be placed prior to treatment response, when the lesion is clearly
      visualized on imaging, accurate image-guided targeting is optimal and thus placement and
      subsequent surgery should be more accurate. If this pilot study demonstrates successful
      performance of the device without device-related complications, it will bring improved value
      to future patients who will require fewer and/or less extensive pre-operative and surgical
      procedures. Some value may also be provided to subjects as the targeting before tumor
      shrinkage is expected to be more accurate.

      Thus, this pilot study will assess the performance of FDA-cleared SCOUT system over a longer
      duration prior to breast and/or axillary lymph node surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants Considered to Have a Successful Surgery
time frame: 31 - 365 days prior to surgery
description: The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.
arm group label: SCOUT device
arm group type: Experimental
description: The study population consists of 25 - 35 adult surgical patient volunteers who plan to have definitive breast cancer surgery at Memorial Healthcare System (MHS) Hospitals after neoadjuvant treatment.
The investigator will identify subjects who meet inclusion/exclusion criteria, obtain patient's consent and schedule the subject for the SAVI SCOUT Surgical Guidance System procedure. All study participants will receive the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Neoadjuvant treatment decisions will be determined by patient's medical oncologist.
intervention type: Device
intervention name: SAVI SCOUT Surgical Guidance System
description: SAVI SCOUT Surgical Guidance System is a non-wire system, which uses nonradioactive light-activated radar, to provide breast surgeons with real-time guidance to locate and remove the target lesion in the breast and/or axillary tissue.
arm group label: SCOUT device
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mary Hayes-Macaluso, MD
role: Principal Investigator
affiliation: Envision Healthcare Scientific Intelligence, Inc.
facility: 
country: United States
citation: Cox CE, Garcia-Henriquez N, Glancy MJ, Whitworth P, Cox JM, Themar-Geck M, Prati R, Jung M, Russell S, Appleton K, King J, Shivers SC. Pilot Study of a New Nonradioactive Surgical Guidance Technology for Locating Nonpalpable Breast Lesions. Ann Surg Oncol. 2016 Jun;23(6):1824-30. doi: 10.1245/s10434-015-5079-x. Epub 2016 Feb 3.
PMID: 26847680
citation: Caudle AS, Yang WT, Mittendorf EA, Black DM, Hwang R, Hobbs B, Hunt KK, Krishnamurthy S, Kuerer HM. Selective surgical localization of axillary lymph nodes containing metastases in patients with breast cancer: a prospective feasibility trial. JAMA Surg. 2015 Feb;150(2):137-43. doi: 10.1001/jamasurg.2014.1086.
PMID: 25517573
citation: Hylton NM, Gatsonis CA, Rosen MA, Lehman CD, Newitt DC, Partridge SC, Bernreuter WK, Pisano ED, Morris EA, Weatherall PT, Polin SM, Newstead GM, Marques HS, Esserman LJ, Schnall MD; ACRIN 6657 Trial Team and I-SPY 1 TRIAL Investigators. Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival-Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL. Radiology. 2016 Apr;279(1):44-55. doi: 10.1148/radiol.2015150013. Epub 2015 Dec 1.
PMID: 26624971
citation: Mango V, Ha R, Gomberawalla A, Wynn R, Feldman S. Evaluation of the SAVI SCOUT Surgical Guidance System for Localization and Excision of Nonpalpable Breast Lesions: A Feasibility Study. AJR Am J Roentgenol. 2016 Oct;207(4):W69-W72. doi: 10.2214/AJR.15.15962. Epub 2016 Jun 15.
PMID: 27304083
responsible party type: Sponsor
mesh term: Breast Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Principal Investigator has left the organization.
point of contact: 