Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage
Status unconfirmed · Not applicable
Conditions studied: Intracranial Hemorrhages, Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT04642443
- Run by
- Sense Diagnostics, LLC
- People needed
- 450
- Starts
- 2020-12-23
- Expected to finish
- 2024-09-30
- Last updated by the study team
- 2023-09-28
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients age 22 years and older
- CT obtained in the mobile stroke unit, emergency department (ED) or hospital
You may not qualify if…
- Female patients who are pregnant or lactating
- SENSE device cannot be applied within 6 hours of a standard of care CT,
- Metallic intracranial clip, coil, device (such as ICP monitor), or penetrating metallic shrapnel,
- Metallic EEG leads in place at the time of planned enrollment,
- Open skull fracture (closed skull fracture is not an exclusion),
- Placement of an intraventricular catheter prior to enrollment, Hemorrhagic transformation of ischemic stroke,) as etiology of ICH,
- Treatment with intravenous thrombolysis or embolectomy prior to enrollment,
- Clinical uncertainty about whether intracranial hemorrhage is present on the pre-enrollment head CT, and
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for SENSE device monitoring or study participation or may confound the outcome of the study.
Where it is running
- Grady — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.