NCT02093182

Brief Summary

The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more. HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool. We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

First QC Date

March 19, 2014

Last Update Submit

December 21, 2016

Conditions

Sub Arachnoid HemorrhageVasospasm

Outcome Measures

Primary Outcomes (1)

  • Accuracy analysis

    The main goal of the study is to check the feasibility of the HeadSense's non-invasive head monitor to check vasospasm in patients which over went SAH. In order to validate the accuracy of the HeadSense's device, a statistical comparison will be done between the acoustic values from the Headsense device and the TCD outcome.

    within the first 30 days

Secondary Outcomes (1)

  • Safety analysis

    within the first 48 hours

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SAH patients with an expected TCD test

You may qualify if:

  • SAH patients with a TCD test
  • Male or Female in the age range of 18-85 years
  • Expected survival \> 14 days

You may not qualify if:

  • Local infection in the ear.
  • Pregnant/lactating women
  • Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
  • Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
  • Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition) Note: As the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc.
  • Enrolled patients treatment will not change due to their participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 20, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

IL(1)