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Observation of Neurosurgical Interventions With Intraoperative Neurophysiological Monitoring IONM

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630785
First Posted: June 28, 2012
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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

  • Trial with surgical intervention

Condition Intervention
Patients Operated on at the Neurosurgery Department Device: Intraoperative Neurophysiological Monitoring IONM

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Observation of Neurosurgical Interventions With Intraoperative Neurophysiological Monitoring IONM

Further study details as provided by University of Zurich:

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

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


Estimated Enrollment: 5000
Study Start Date: January 2012
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IONM patients
all patients where surgery requires IONM
Device: Intraoperative Neurophysiological Monitoring IONM
Intraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01630785     History of Changes
Other Study ID Numbers: 121
First Submitted: June 21, 2012
First Posted: June 28, 2012
Last Update Posted: June 1, 2016
Last Verified: May 2016