<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/NCT03245138</url>
  </required_header>
  <id_info>
    <org_study_id>ETV versus VPS in iNPH</org_study_id>
    <nct_id>NCT03245138</nct_id>
  </id_info>
  <brief_title>Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus</brief_title>
  <official_title>Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</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>
      An endoscopic third ventriculostomy is considered to be successful in idiopathic normal&#xD;
      pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality&#xD;
      data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic&#xD;
      third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled,&#xD;
      multicenter study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt&#xD;
      insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with&#xD;
      obstructive hydrocephalus. However, in the last decade several reports highlighted an success&#xD;
      of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to&#xD;
      compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal&#xD;
      pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled&#xD;
      multicenter study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Kiefer Index</measure>
    <time_frame>1 year</time_frame>
    <description>Improvment of at least 2 points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery Index</measure>
    <time_frame>1 year</time_frame>
    <description>Improvment of at least 2 points</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Normal Pressure Hydrocephalus</condition>
  <arm_group>
    <arm_group_label>endoscopic third ventriculostomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>endoscopic third ventriculostomy for the treatment of iNPH</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ventricular peritoneal shunt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Third Ventriculostomy</intervention_name>
    <description>patients receive an endoscopic third ventriculotomy as surgical procedure</description>
    <arm_group_label>endoscopic third ventriculostomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ventriculo-Peritoneal Shunting</intervention_name>
    <description>patients receive an ventriculo-peritoneal shunt as surgical procedure</description>
    <arm_group_label>ventricular peritoneal shunt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 50 years&#xD;
&#xD;
          -  gait disturbances typical for iNPH&#xD;
&#xD;
          -  symptoms Duration less than 36months&#xD;
&#xD;
          -  exclusion of obstructive hydrocephalus&#xD;
&#xD;
          -  positive spinal TAP-test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  malignant disease&#xD;
&#xD;
          -  other diseases of the CNS (Parkinson, dementia)&#xD;
&#xD;
          -  secondary communicating hydrocephalus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17489</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sascha Marx, MD</last_name>
      <phone>00493834866163</phone>
      <email>marxs@uni-greifswald.de</email>
    </contact>
    <contact_backup>
      <last_name>Henry WS Schroeder, MD, PhD</last_name>
      <phone>00493834866163</phone>
      <email>henry.schroeder@uni-greifswald.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University Medicine Göttingen</name>
      <address>
        <city>Göttingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ingo Fiss, MD</last_name>
      <email>ingo.fiss@med.uni-goettingen.de</email>
    </contact>
    <contact_backup>
      <last_name>Veit Rohde, MD, PhD</last_name>
      <email>veit.rohde@med.uni-goettingen.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Klinikum Neubrandenburg</name>
      <address>
        <city>Neubrandenburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aleksandra Smilgrin, MD</last_name>
      <email>smilgina@dbknb.de</email>
    </contact>
    <contact_backup>
      <last_name>Michael Fritsch, MD, PhD</last_name>
      <email>fritschm@dbknb.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medicine Greifswald</investigator_affiliation>
    <investigator_full_name>Sascha Marx</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>endoscopic third ventriculostomy</keyword>
  <keyword>ventricular peritoneal shunt</keyword>
  <keyword>communicating hydrocephalus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</mesh_term>
    <mesh_term>Hydrocephalus, Normal Pressure</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/NCT03245138
org study id: ETV versus VPS in iNPH
nct id: NCT03245138
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An endoscopic third ventriculostomy is considered to be successful in idiopathic normal
      pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality
      data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic
      third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled,
      multicenter study.
The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt
      insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with
      obstructive hydrocephalus. However, in the last decade several reports highlighted an success
      of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to
      compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal
      pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled
      multicenter study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Kiefer Index
time frame: 1 year
description: Improvment of at least 2 points
measure: Recovery Index
time frame: 1 year
description: Improvment of at least 2 points
arm group label: endoscopic third ventriculostomy
arm group type: Experimental
description: endoscopic third ventriculostomy for the treatment of iNPH
arm group label: ventricular peritoneal shunt
arm group type: Active Comparator
description: Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH
intervention type: Procedure
intervention name: Endoscopic Third Ventriculostomy
description: patients receive an endoscopic third ventriculotomy as surgical procedure
arm group label: endoscopic third ventriculostomy
intervention type: Procedure
intervention name: Ventriculo-Peritoneal Shunting
description: patients receive an ventriculo-peritoneal shunt as surgical procedure
arm group label: ventricular peritoneal shunt
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Medicine Greifswald
investigator full name: Sascha Marx
investigator title: Principal Investigator
mesh term: Hydrocephalus
mesh term: Hydrocephalus, Normal Pressure
sharing ipd: Undecided