NCT04642443

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

A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device's Ability to Detect Intracranial Hemorrhage

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Sense Diagnostics, LLC · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a two-stage, pivotal, prospective, nonrandomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scans. All subjects who meet eligibility criteria should be enrolled. An algorithm has been developed for detecting ICH, which will now be tested in this independent cohort of subjects. CT scans will be grouped into: 1) ICH, or 2) non- ICH. Enrollment will continue until 120 subjects with and 120 without ICH have been enrolled. An interim analysis will occur after \~60 subjects each with and without ICH have been enrolled and the sample size may be increased at the direction of the DMC as warranted. In Stage 1, 150 subjects (with primary spontaneous ICH or traumatic intracranial hemorrhage) were enrolled for the development of a hemorrhage detection algorithm. In Stage 2, the algorithm developed in Stage 1 will be tested in an independent cohort of up to 300 subjects. All subjects who meet eligibility criteria should be enrolled. The gold standard will be the CT results. The algorithm established in Stage 1 will be tested in this independent cohort of subjects. CT scans will be grouped into: 1) ICH or, 2) non-ICH. Enrollment will continue until \~60 subjects each with and without ICH have been enrolled. An interim analysis will occur after \~60 subjects each with and without ICH have been enrolled and the sample size may be increased at the direction of the DMC as warranted. All subjects' CT images will be reviewed by an independent neuroradiology core for classification as ICH or non-ICH, and ICH volume estimation. The treating clinicians and independent neuroradiologist will be blinded to the SENSE device findings.

Conditions

• Intracranial Hemorrhages
• Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-23
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2020-11-24
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study