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

NCT01801306 | Completed DMC

• 1 other identifier: CIV-12-04-006261
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Spontaneous Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage

  Day 90 after Removal of Medical Device

Study Arms (1)

NeMoProbe

OTHER

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).

Device: NeMo Probe

Interventions

NeMo Probe DEVICE

A new minimal-invasive brain tissue probe applying near infrared spectroscopy

NeMoProbe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Women of childbearing potential must have a negative serum pregnancy test
• Written informed consent obtained by a legal representative

You may not qualify if:

• 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

Sponsors & Collaborators

• NeMoDevices AG: lead

Study Sites (1)

Department of Neurosurgery, University Hospital Heidelberg

Heidelberg, 69221, Germany

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Seule, MD

  Department of Neurosurgery, University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 28, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

DE (1)