VasospasmNCT02071875
Comparing the Nautilus NeuroWaveTM to TCD or DSA for the Detection of Vasospasm
An observational study of Vasospasm, run by Jan Medical, Inc. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasospasm
- What is being tested?
- Nautilus NeuroWaveTM recording
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
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
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.
Read the 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.
- Conditions
- Vasospasm
- Being tested
- Nautilus NeuroWaveTM recording
- Keywords
- Vasospasm, Aneurysm, SAH, Nautilus NeuroWave
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nautilus NeuroWaveTM recordingDevice
Nautilus NeuroWaveTM recording 15 minute recording with Nautilus NeuroWave Neurodiagnostic .
| Study group | Role | What they receive |
|---|---|---|
| Nautilus NeuroWaveTM recording | Nautilus NeuroWaveTM recording 15 minute recording Receives: Device: Nautilus NeuroWaveTM recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (moderate or severe)
Efficacy at identifying moderate or severe vasospasm. Reference diagnosis will be with TCD and where available DSA
Measured: 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
Measured: Within 5 minutes of recording
Secondary outcomes (3)
Sensitivity at detecting any vasospasm
Efficacy at identifying vasospasm either mild, moderate or severe. Reference standard will be TCD and DSA where available.
Measured: 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
Measured: 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.
Measured: Within 5 minutes of recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2020
- Study completionDec 2020
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Neulen, MD, Principal investigator, University Medical Center of the Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071875
- Sponsor's protocol ID
- NMDCL100212-OCA
- Status last verified
- Jun 2022
- First submitted
- 24 Feb 2014
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02071875
- Acronym / sponsor ID
- NMDCL100212-OCA
- Conditions
- Vasospasm
- Keywords
- Vasospasm, Aneurysm, SAH, Nautilus NeuroWave
- Study type
- Observational
- Recruitment status
- TerminatedReason 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
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nautilus NeuroWaveTM recording | – | Device: Nautilus NeuroWaveTM recordingNautilus NeuroWaveTM recording 15 minute recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nautilus NeuroWaveTM recordingNautilus NeuroWaveTM recording 15 minute recording with Nautilus NeuroWave Neurodiagnostic . | Device | Nautilus NeuroWaveTM recording |
Primary outcome
Sensitivity (moderate or severe)
Time frame: Within 5 minutes from end of recording
Efficacy at identifying moderate or severe vasospasm. Reference diagnosis will be with TCD and where available DSA
Specificity
Time frame: Within 5 minutes of recording
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
3 secondary outcomes
Sensitivity at detecting any vasospasm
Time frame: Within 5 minutes of recording
Specificity
Time frame: Within 5 minutes of end of recording
Location of vasospasm
Time frame: Within 5 minutes of recording
Results and safety
The study was stopped early (reason given: Study recruitment was put on hold for interim data analysis and during this time period the PI requested to pre-maturely terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Neulen, MD principal investigator
University Medical Center of the Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasospasm, run by Jan Medical, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study recruitment was put on hold for interim data analysis and during this time period the PI requested to pre-maturely terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (moderate or severe) (time frame: Within 5 minutes from end of recording). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.