NCT01802762

Brief Summary

To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

4.1 years

First QC Date

February 24, 2013

Last Update Submit

September 4, 2017

Conditions

Subarachnoid HemorrhageOptical Imaging

Outcome Measures

Primary Outcomes (1)

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

    Feasibility: User acceptance: For NeMo Probes in comparison to conventional probes for intracranial pressure (ICP-) monitoring; for NeMo Patch in comparison to patches for electroencephalography (EEG) monitoring. Detailled evaluation of user acceptance: * Incidence of concerns of users in relation to the installation, function and removal of the NeMo System (= NeMo Probe, NeMo Patch, NeMo Control Unit and NeMo Software pre-installed on a Medical PC) * User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional devices Accuracy of measurements: -Patients: Results from repeated measurements of mean transit time of ICG (mttICG), cerebral blood flow (CBF) and cerebral blood volume (CBV) Safety parameters: Incidence of complications (infections, brain tissue damage, haemorrhage) compared to historical series (patches for EEG and for BIS measurements; conventional probes for ICP monitoring)

    Day 28 after removal of medical device

Secondary Outcomes (1)

  • To demonstrate the ability of the neuromonitoring system to detect secondary ischemic events in patients with severe subarachnoid haemorrhage (SAH) or severe traumatic brain injury (TBI).

    Day 28 after removal of medical device

Study Arms (1)

NeMo Patch and NeMo Probe

OTHER

TBI and SAH patients, one arm

Device: NeMo Patch and NeMo Probe

Interventions

NeMo Patch and NeMo ProbeDEVICE

A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)

NeMo Patch and NeMo Probe

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or female patient, ≥ 18 and ≤ 75 years
  • Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8)
  • Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days
  • Negative pre-treatment serum pregnancy test for female patients with childbearing potential

You may not qualify if:

  • Known kidney disease, defined as plasma creatinine \> 120 µmol/l
  • Known liver disease, defined as GOT \> 200U/l
  • History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism
  • Pre-existing disability and/or legal representative
  • Participation in another interventional clinical trial within the last 30 days before start of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Neurosurgery, Medical University of Graz

Graz, 8036, Austria

Location

Neurointensive Care Unit, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

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 24, 2013

First Posted

March 1, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

AU(1)CH(1)