Spontaneous Subarachnoid HemorrhageNCT01801306
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
A study testing NeMo Probe in people with Spontaneous Subarachnoid Hemorrhage, run by NeMoDevices AG at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spontaneous Subarachnoid Hemorrhage
- What is being tested?
- NeMo Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, 69221
About this study
Official title: A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage
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
- Being tested
- NeMo Probe
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeMo ProbeDevice
A new minimal-invasive brain tissue probe applying near infrared spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: NeMo Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
Measured: 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
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.
Measured: Day 90 after Removal of Medical Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeMoDevices AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Seule, MD, Principal investigator, Department of Neurosurgery, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801306
- Sponsor's protocol ID
- CIV-12-04-006261
- Status last verified
- Jun 2014
- First submitted
- 25 Feb 2013
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01801306
- Acronym / sponsor ID
- CIV-12-04-006261
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NeMoDevices AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeMoProbe | Other | Device: NeMo ProbeThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeMo ProbeA new minimal-invasive brain tissue probe applying near infrared spectroscopy | Device | NeMoProbe |
Primary outcome
To assess the feasibility of the neuromonitoring system and accuracy of the measurement values
Time frame: Day 90 after Removal of Medical Device
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):
1 secondary outcome
To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage
Time frame: Day 90 after Removal of Medical Device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Seule, MD principal investigator
Department of Neurosurgery, University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeMo Probe in people with Spontaneous Subarachnoid Hemorrhage, run by NeMoDevices AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of the neuromonitoring system and accuracy of the measurement values (time frame: Day 90 after Removal of Medical Device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.