NCT02772471

Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: HeadSense Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.

Detailed description

A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.

Conditions

• Brain Injuries
• Intracranial Hypertension

Interventions

Type	Name	Description
DEVICE	HS-1000

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2016-05-13
• Last updated: 2016-05-13

Locations

1 site across 1 country: Norway