A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy

Spontaneous Subarachnoid Hemorrhage Clinical Trial

Official title:

A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801306
• Other study ID #: CIV-12-04-006261
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: June 17, 2014
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: NeMoDevices AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hemorrhage
• Spontaneous Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• NeMo Probe
A new minimal-invasive brain tissue probe applying near infrared spectroscopy

Locations

Country	Name	City	State
Germany	Department of Neurosurgery, University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
NeMoDevices AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of the neuromonitoring system and accuracy of the measurement values	Feasibility: User acceptance rate in comparison to conventional probes for ICP-monitoring. The following parameters will be analysed: Incidence of concerns of users in relation to the installation of the NeMo System; Incidence of concerns of users in relation to the function of the NeMo System Incidence of concerns of users in relation to the removal of the NeMo System; User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional probes for ICP monitoring Accuracy of measurement values: Results from repeated measurements of mttICG, CBV, and CBF.; Safety endpoints: -Adverse events profile (including adverse device effects): Incidence of complications (infections, brain tissue damage, hemorrhage) in comparison to historical series (conventional probes for ICP-monitoring):	Day 90 after Removal of Medical Device	Yes
Secondary	To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage	Results concerning the response to cortical spreading depolarization (CSD) monitored with electrocorticography (ECoG): Increase of brain tissue oxygenation (SbtO2), total hemoglobin (dHbtotal, aHbtotal), CBV, CBV Hb and CBF >20% Decrease of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF >20% Changes of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF <20%; Results concerning the sensitivity and specificity to detect delayed cerebral ischemia (DCI) monitored with ptiO2 and MD: Correlation of CBF values <15 ml/100g/min with defined criteria for DCI (ptiO2 <15 mmHg, Gluc brain<0.7 mmol/l, Lactate-Pyruvate-Ratio >40), number of false negative and false positive events, Receiver Operating Characteristic (ROC) curve.	Day 90 after Removal of Medical Device	No