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

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.

Study Overview

• Status: Terminated
• Conditions: Vasospasm
• Intervention / Treatment: Device: Nautilus NeuroWaveTM recording

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • University Medical Center of the Johannes Gutenberg University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nautilus NeuroWaveTM recording; Nautilus NeuroWaveTM recording 15 minute recording	Device: Nautilus NeuroWaveTM recording; Nautilus NeuroWaveTM recording 15 minute recording with Nautilus NeuroWave Neurodiagnostic .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity at detecting any vasospasm	Efficacy at identifying vasospasm either mild, moderate or severe. Reference standard will be TCD and DSA where available.	Within 5 minutes of recording
Specificity	Rate of false positives using TCD and where available DSA as the reference standard. False positive is a recording determined as no vasospasm by TCD or DSA that is determined by the NNW as either mild, moderate or severe vasospasm	Within 5 minutes of end of recording
Location of vasospasm	With TCD and DSA, when available, as reference standards, the efficacy at locating any vasospasm as ocurring in the left, right or back of the cranium. The measure will be what % of correctly called vasospasm was correctly located.	Within 5 minutes of recording

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device related adverse events	The total number of adverse events reported by the clinical site	Within 1 week of end of recording
Ease of use	Number of recordings that were not of adequate quality for a determination. This will be a no call	Within 5 minutes from end of recording

Collaborators and Investigators

• Sponsor: Jan Medical, Inc.
• Investigators: Principal Investigator: Axel Neulen, MD, University Medical Center of the Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: SAH; Vasospasm; Aneurysm; Nautilus NeuroWave
• Other Study ID Numbers: NMDCL100212-OCA