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

Sense Diagnostics Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•Subjects who meet all of the following inclusion criteria will be considered candidates for study enrollment:1. Male or female patients age 22 years and older 2. CT obtained in the mobile stroke unit, emergency department (ED) or hospital
•Informed consent provided by study subject or, if subject is unable, by subject’s next of kin or legal guardian.

•All subjects meeting any of the following criteria will be excluded from this study:
•1. Female patients who are pregnant or lactating
•2. SENSE device cannot be applied within 6 hours of a standard of care CT,
•3. Metallic intracranial clip, coil, device (such as ICP monitor),or penetrating metallic shrapnel,
•4. Metallic EEG leads in place at the time of planned enrollment,
•5. Open skull fracture (closed skull fracture is not an exclusion),
•6. Placement of an intraventricular catheter prior to enrollment,
•7. Hemorrhagic transformation of ischemic stroke,) as etiology of ICH,
•8. Treatment with intravenous thrombolysis or
•embolectomy prior to enrollment,
•9. Clinical uncertainty about whether intracranial
•hemorrhage is present on the pre-enrollment head
•10. 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.

发起方

Sense Diagnostics Inc