A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
NCT ID: NCT01801306
Last Updated: 2014-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2013-03-31
2014-02-28
Brief Summary
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To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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NeMoProbe
The NeMo System is used for intracranial pressure (ICP) and brain temperature monitoring, as well as the determination of the brain tissue oxygenation saturation (SbtO2) and cerebral blood flow. The sensors for NIRS are implemented into a conventional brain tissue probe for ICP monitoring (NeMo Probe).
NeMo Probe
A new minimal-invasive brain tissue probe applying near infrared spectroscopy
Interventions
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NeMo Probe
A new minimal-invasive brain tissue probe applying near infrared spectroscopy
Eligibility Criteria
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Inclusion Criteria
* Patients with high-grade subarachnoid hemorrhage (WFNS 4-5)
* Decreased level of consciousness with the need for intracranial pressure monitoring
* Successful exclusion of the ruptured aneurysm with clipping or coiling
* Women of childbearing potential must have a negative serum pregnancy test
* Written informed consent obtained by a legal representative
Exclusion Criteria
* Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure \> NYHA II)
* Cerebrospinal fluid infection or signs of meningoencephalitis
* Acute respiratory distress syndrome (ARDS), pulmonary edema
* Preexisting coagulation disorder
* Patients with current alcohol or drug abusus or dependence
* Patients with a history of hypersensitivity against indocyanine green or sodium iodine
* Patients with thyroid disease causing hyperthyroidism
* Breast-feeding women
* Patients committed to an institution based on official directive or court order
18 Years
75 Years
ALL
No
Sponsors
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NeMoDevices AG
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Seule, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, University Hospital Heidelberg
Locations
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Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, , Germany
Countries
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Other Identifiers
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CIV-12-04-006261
Identifier Type: -
Identifier Source: org_study_id
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