Study Stopped
Study recruitment was put on hold for interim data analysis and during this time period the PI requested to pre-maturely terminate the study
Comparing the Nautilus NeuroWaveTM to TCD or DSA for the Detection of Vasospasm
A Non-Randomized, Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM System to Transcranial Doppler or DSA as an Aid to Diagnosing Vasospasm
1 other identifier
observational
43
1 country
1
Brief Summary
To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in detection of moderate and severe vasospasm for detection of vasospasm in patients with subarachnoid hemorrhage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Longer than P75 for all trials
1 active site
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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 1, 2022
June 1, 2022
7.1 years
February 24, 2014
June 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensitivity (moderate or severe)
Efficacy at identifying moderate or severe vasospasm. Reference diagnosis will be with TCD and where available DSA
Within 5 minutes from end of recording
Specificity
Rate of false positives using TCD and where available DSA as the reference standard. False positive is a recording judged mild or no vasospasm by TCD or DSA that is determined by the NNW as moderate or severe
Within 5 minutes of recording
Secondary Outcomes (3)
Sensitivity at detecting any vasospasm
Within 5 minutes of recording
Specificity
Within 5 minutes of end of recording
Location of vasospasm
Within 5 minutes of recording
Other Outcomes (2)
Incidence of device related adverse events
Within 1 week of end of recording
Ease of use
Within 5 minutes from end of recording
Study Arms (1)
Nautilus NeuroWaveTM recording
Nautilus NeuroWaveTM recording 15 minute recording
Interventions
Nautilus NeuroWaveTM recording 15 minute recording with Nautilus NeuroWave Neurodiagnostic .
Eligibility Criteria
Subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm
You may qualify if:
- Male or female subjects 18 years of age or older.
- Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm.
- Signed informed consent from the patient or the patient's Legally Authorized Representative
You may not qualify if:
- Unstable medical illness such that recordings might interfere with medical care.
- Presence of head bandages or brain monitors that might physically interfere with the NNW recording device.
- Current hemicraniectomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Axel Neulen, MD
University Medical Center of the Johannes Gutenberg University Mainz
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 26, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
July 1, 2022
Record last verified: 2022-06