An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

Vasospasm Clinical Trial

Official title:

A Retrospective, Open-Label, Non-Randomized, Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Vasospasm Patients After Sub Arachnoid Hemorrhage

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02093182
• Other study ID #: HS-007
• Secondary ID: 0026-14-TLV
• Status: Withdrawn
• Phase: N/A
• First received: March 19, 2014
• Last updated: December 21, 2016
• Est. completion date: October 2014

Study information

• Verified date: December 2016
• Source: HeadSense Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• SAH patients with a TCD test

• Male or Female in the age range of 18-85 years

• Expected survival > 14 days

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemorrhage
• Sub Arachnoid Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
HeadSense Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety analysis	The HeadSense device is non-invasive and radiation free, therefore no major safety issues are expected.; During the trial, the patient will be monitored to make sure that no danger or damage is caused by the device. Although there is a small chance of adverse events, potential safety issues include: Perforation of the ear drum, caused by inserting the device to the patient's ears; Allergic reaction caused by skin contact with the device (the parts that are attached to the skin are taken from an off the shelf stethoscope, so this is very unlikely to happen); Damage to hearing, caused by the generated sound (the sound is 10Db in strength and is being generated for 10 seconds, so hearing damage is very unlikely to happen	within the first 48 hours	Yes