Clinical trial NCT02071875: Comparing the Nautilus NeuroWaveTM to TCD or DSA for the Detection of Vasospasm
Official title: A Non-Randomized, Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM System to Transcranial Doppler or DSA as an Aid to Diagnosing Vasospasm
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vasospasm
Keywords: Vasospasm
Aneurysm
SAH
Nautilus NeuroWave
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm

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.

Detailed description: This study is a prospective, comparative, non-randomized study in subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm. The study will be conducted in one center.

The primary objective of Phase I of this non-significant risk study is proof of principle. During this phase the goal is to build a library of Jan Medical NNW system recordings from patients with moderate and severe vasospasms. A signature for detecting vasospasms will be developed using the signals from a vasospasm epoch to a patient's individual baseline recording and confirming the presence of vasospasm by comparison of Jan Medical NNW system data to TCD and, when available Digital Subtraction Angiography (DSA). The number of patients required for Phase I is estimated to be 20 patients with confirmed moderate or severe vasospasm with a minimum of 10 these patients having at least one severe vasospasm recording confirmed by TCD or DSA. Daily recordings are to be taken.

During Phase II the Jan Medical NNW system will independently utilize the signatures identified in Phase I to identify the presence or absence of moderate and severe vasospasm in a blinded recording. This recording will be compared to TCD or DSA, when DSA is available, for analysis of sensitivity and specificity. Up to 50 subjects will be enrolled in Phase II. When possible, multiple recordings will be obtained from each subject to include recordings with and without vasospasm.

Duration of each subject's enrollment in this study is limited to the period of time when Jan Medical NNW system recordings are performed. No additional tests or procedures will be performed during participation in this study and all other data collected (including TCD or DSA) will be based on available evaluations conducted as part of the patient's standard of care. Upon completing the last Jan Medical NNW system recording or when no further data collection is expected, the subject will be exited from the study.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 years of age or older.
2. Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm.
3. Signed informed consent from the patient or the patient's Legally Authorized Representative

Exclusion Criteria:

1. Unstable medical illness such that recordings might interfere with medical care.
2. Presence of head bandages or brain monitors that might physically interfere with the NNW recording device.
3. Current hemicraniectomy.

Primary outcomes:
measure: Sensitivity (moderate or severe)
timeFrame: Within 5 minutes from end of recording
measure: Specificity
timeFrame: Within 5 minutes of recording
Secondary outcomes:
measure: Sensitivity at detecting any vasospasm
timeFrame: Within 5 minutes of recording
measure: Specificity
timeFrame: Within 5 minutes of end of recording
measure: Location of vasospasm
timeFrame: Within 5 minutes of recording
Other outcomes:
measure: Incidence of device related adverse events
timeFrame: Within 1 week of end of recording
measure: Ease of use
timeFrame: Within 5 minutes from end of recording
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg University Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: University Medical Center of the Johannes Gutenberg University Mainz
name: Axel Neulen, MD
role: PRINCIPAL_INVESTIGATOR
References: