<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/NCT02989363</url>
  </required_header>
  <id_info>
    <org_study_id>Study ECOPRES</org_study_id>
    <nct_id>NCT02989363</nct_id>
  </id_info>
  <brief_title>Evaluation of the Use of Resources and Costs</brief_title>
  <official_title>Evaluation of the Use of Resources and Costs With O-arm in Brain Stimulation Deep Surgeries and Complex Back Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigacion Sanitaria La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigacion Sanitaria La Fe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS)&#xD;
      surgeries and complex back surgeries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To measure the use of health resources in application A (with DBS) and in application B&#xD;
      (vertebral fusions), in patients in the intervention group with O-arm and in the control&#xD;
      group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical,&#xD;
      post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Surgical Incision</condition>
  <arm_group>
    <arm_group_label>O-Arm in deep brain stimulation surgeries (DBS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group Not O-Arm in deep brain stimulation surgeries</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>O-Arm in complex back surgeries (RAQUIS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group Not O-Arm in complex back surgeries (RAQUIS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Device O-Arm in DBS</intervention_name>
    <description>Deep brain stimulation surgeries with device O-Arm</description>
    <arm_group_label>O-Arm in deep brain stimulation surgeries (DBS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Device O-Arm in RAQUIS</intervention_name>
    <description>Complex back surgeries with the device O-Arm</description>
    <arm_group_label>O-Arm in complex back surgeries (RAQUIS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Not device O-Arm in DBS</intervention_name>
    <description>Deep brain stimulation surgeries without the device O-Arm</description>
    <arm_group_label>Control group Not O-Arm in deep brain stimulation surgeries</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Not device O-Arm in RAQUIS</intervention_name>
    <description>Complex back surgeries without the device O-Arm</description>
    <arm_group_label>Control group Not O-Arm in complex back surgeries (RAQUIS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Patients with indication for DBS surgery for movement disorders, epilepsy and&#xD;
             obsessive-compulsive disorder, or for cervical, dorsal or lumbar fusion surgery levels&#xD;
             1,2 and 3 in a degenerative disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had pediatric instrumented surgery.&#xD;
&#xD;
          -  Patients in which the pedicle screws are inserted for neoplasia or other disease.&#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>Carlos Botella</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Investigación Sanitaria La Fe</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elena Garcia</last_name>
    <phone>0034961246711</phone>
    <email>investigacion_clinica@iislafe.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura Segura</last_name>
    <phone>0034961246711</phone>
    <email>monitor1@iislafe.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto de Investigación Sanitaria La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elena Garcia</last_name>
      <phone>34961246611</phone>
      <email>investigacion_clinica@iislafe.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>deep brain surgery and complex back surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02989363
org study id: Study ECOPRES
nct id: NCT02989363
lead sponsor: 
collaborator: 
has dmc: No
Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS)
      surgeries and complex back surgeries
To measure the use of health resources in application A (with DBS) and in application B
      (vertebral fusions), in patients in the intervention group with O-arm and in the control
      group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical,
      post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
time frame: 12 months
measure: Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)
time frame: 6 months
measure: Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery
time frame: 6 months
measure: Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery
time frame: 12 months
measure: Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary
time frame: 12 months
measure: Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery
time frame: 6 months
measure: Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery
time frame: 12 months
measure: Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention
time frame: 6 months
measure: Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention
time frame: 12 months
arm group label: O-Arm in deep brain stimulation surgeries (DBS)
arm group type: Experimental
description: Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)
arm group label: Control group Not O-Arm in deep brain stimulation surgeries
arm group type: Experimental
description: Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)
arm group label: O-Arm in complex back surgeries (RAQUIS)
arm group type: Experimental
description: Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)
arm group label: Control group Not O-Arm in complex back surgeries (RAQUIS)
arm group type: Experimental
description: Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)
intervention type: Procedure
intervention name: Device O-Arm in DBS
description: Deep brain stimulation surgeries with device O-Arm
arm group label: O-Arm in deep brain stimulation surgeries (DBS)
intervention type: Procedure
intervention name: Device O-Arm in RAQUIS
description: Complex back surgeries with the device O-Arm
arm group label: O-Arm in complex back surgeries (RAQUIS)
intervention type: Procedure
intervention name: Not device O-Arm in DBS
description: Deep brain stimulation surgeries without the device O-Arm
arm group label: Control group Not O-Arm in deep brain stimulation surgeries
intervention type: Procedure
intervention name: Not device O-Arm in RAQUIS
description: Complex back surgeries without the device O-Arm
arm group label: Control group Not O-Arm in complex back surgeries (RAQUIS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Botella
role: Principal Investigator
affiliation: Instituto de Investigación Sanitaria La Fe
last name: Elena Garcia
phone: 0034961246711
email: investigacion_clinica@iislafe.es
last name: Laura Segura
phone: 0034961246711
email: monitor1@iislafe.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Surgical Wound
sharing ipd: Undecided