<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/NCT01731379</url>
  </required_header>
  <id_info>
    <org_study_id>NL 40893.031.12</org_study_id>
    <nct_id>NCT01731379</nct_id>
  </id_info>
  <brief_title>Optical Detection of Peripheral Nerve Bundles During Surgery</brief_title>
  <acronym>NerveSpect</acronym>
  <official_title>In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Electronics Nederland B.V. acting through Philips CTO organization</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Philips Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of application possibilities of optical spectroscopy within the field of&#xD;
      surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the&#xD;
      possibility to specifically differentiate between different (human) tissues. The hypothesis&#xD;
      is that incorporation of this technique into existing medical devices (e.g. medical blade)&#xD;
      would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during&#xD;
      surgery can lead to decreased postoperative morbidity rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this pilot study is to prove that an investigational optical spectroscopy system&#xD;
      can provide accurate identification of nerve tissue during surgery.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      The goal of this pilot study is to evaluate whether optical spectroscopy is able to&#xD;
      differentiate between nerve tissue and surrounding tissue.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      During the measurement procedure, possible improvements of the measurement hardware will be&#xD;
      recorded and the handling of the optical spectroscopy system during surgery will be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differentiation between nerve tissue and its surrounding tissue</measure>
    <time_frame>Day 0</time_frame>
    <description>Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Malignant Lymphoma of Lymph Nodes of Inguinal Region</condition>
  <condition>Malignant Lymphoma of Lymph Nodes of Axillary</condition>
  <condition>Malignant Lymphoma of Lymph Nodes of the Cervix</condition>
  <condition>Carcinoma of Parotid Gland</condition>
  <condition>Colon Rectal Cancer Tubulovillous Adenocarcinoma</condition>
  <condition>Tumor of Soft Tissue of Head, Face and Neck</condition>
  <arm_group>
    <arm_group_label>Surgical resections</arm_group_label>
    <description>Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical resection</intervention_name>
    <description>Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.</description>
    <arm_group_label>Surgical resections</arm_group_label>
    <other_name>lymph node dissection</other_name>
    <other_name>resection of parotid gland</other_name>
    <other_name>rectal surgery</other_name>
    <other_name>soft tumor resection</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are&#xD;
        scheduled for an elective inguinal, axillary or cervical lymph node dissection, or&#xD;
        parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients&#xD;
        undergoing resection of a soft tissue tumour.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planned for elective inguinal, axillary or cervical lymph node dissection or&#xD;
             parotidectomy , patients with rectal cancer undergoing rectal surgery and patients&#xD;
             undergoing resection of a soft tissue tumour.&#xD;
&#xD;
          -  Patients that have provided a signed informed consent&#xD;
&#xD;
          -  Patients ≥ 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with suspected sensitivity to light; e.g. patients who have had photodynamic&#xD;
        therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theo Ruers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 2, 2015</last_update_submitted>
  <last_update_submitted_qc>November 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spectroscopy</keyword>
  <keyword>nerve</keyword>
  <keyword>muscle</keyword>
  <keyword>fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Soft Tissue Neoplasms</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/NCT01731379
org study id: NL 40893.031.12
nct id: NCT01731379
lead sponsor: 
collaborator: 
has dmc: Yes
Investigation of application possibilities of optical spectroscopy within the field of
      surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the
      possibility to specifically differentiate between different (human) tissues. The hypothesis
      is that incorporation of this technique into existing medical devices (e.g. medical blade)
      would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during
      surgery can lead to decreased postoperative morbidity rates.
The aim of this pilot study is to prove that an investigational optical spectroscopy system
      can provide accurate identification of nerve tissue during surgery.

      Primary Objective:

      The goal of this pilot study is to evaluate whether optical spectroscopy is able to
      differentiate between nerve tissue and surrounding tissue.

      Secondary Objective:

      During the measurement procedure, possible improvements of the measurement hardware will be
      recorded and the handling of the optical spectroscopy system during surgery will be
      evaluated.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Differentiation between nerve tissue and its surrounding tissue
time frame: Day 0
description: Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations
arm group label: Surgical resections
description: Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
intervention type: Procedure
intervention name: Surgical resection
description: Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
arm group label: Surgical resections
other name: lymph node dissection
other name: resection of parotid gland
other name: rectal surgery
other name: soft tumor resection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theo Ruers, MD
role: Principal Investigator
affiliation: Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Soft Tissue Neoplasms