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Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage

NCT04642443 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2023-09-28

No results posted yet for this study

Summary

This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the detection and monitoring of intracranial hemorrhages.

Conditions

Interventions

DEVICE

SENSE Device

The SENSE Device is indicated for the monitoring of intracranial hemorrhage by detecting a suspected increase in blood volume within the cranial vault. It is an adjunctive device to the clinical evaluation in the acute hospital setting of patients 22 years of age or older with suspected or known intracranial hemorrhage. The device is indicated for use to monitor patients for intracranial hemorrhage expansion between CT scans but should not serve as a substitute for these scans.

Sponsors & Collaborators

  • Sense Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Jonathan Ratcliff, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2024-06-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04642443 on ClinicalTrials.gov