CompletedNot Applicable

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

Germany3 participantsStarted 2013-03

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the feasibility of the neuromonitoring system and accuracy of the measurement values

Timeframe: Day 90 after Removal of Medical Device

Trial details

NCT IDNCT01801306

SponsorNeMoDevices AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

View on ClinicalTrials.gov More Spontaneous Subarachnoid Hemorrhage trials