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Observation of Neurosurgical Interventions With Intraoperative Neurophysiological Monitoring IONM

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ClinicalTrials.gov Identifier: NCT01630785
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2012
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring

  • Trial with surgical intervention

Condition or disease Intervention/treatment
Patients Operated on at the Neurosurgery Department Device: Intraoperative Neurophysiological Monitoring IONM

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Observation of Neurosurgical Interventions With Intraoperative Neurophysiological Monitoring IONM
Study Start Date : January 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Group/Cohort Intervention/treatment
IONM patients
all patients where surgery requires IONM
Device: Intraoperative Neurophysiological Monitoring IONM
Intraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany



Primary Outcome Measures :
  1. oncological outcome [ Time Frame: 5 years ]
    overall survival, progression free survival

  2. neurological outcome [ Time Frame: 1 year ]
    validated scales like Karnofsky or NIHSS



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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients whose surgery involved intraoperative neurophysiological monitoring
Criteria
Inclusion criteria: Patients whose surgery involved intraoperative neurophysiological monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630785


Locations
Switzerland
University Hospital Zurich, Neurosurgery
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Johannes Sarnthein, MD University Hospital Zurich, Division of Neurosurgery

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01630785     History of Changes
Other Study ID Numbers: 121
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016