Status:
COMPLETED
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
Lead Sponsor:
NeMoDevices AG
Conditions:
Spontaneous Subarachnoid Hemorrhage
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values. To demonstrate the ability of the NeMo probe to detect c...
Eligibility Criteria
Inclusion
- Males and females aged 18-75 years (inclusive)
- 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
- Significant kidney and/or liver disease
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01801306
Start Date
March 1 2013
End Date
February 1 2014
Last Update
June 18 2014
Active Locations (1)
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1
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, Germany, 69221