RECRUITING

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

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Conditions

Intracranial HemorrhagesTraumatic Brain Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-23
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04642443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients age 22 years and older
  2. * CT obtained in the mobile stroke unit, emergency department (ED) or hospital
  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, Hemorrhagic transformation of ischemic stroke,) as etiology of ICH,
  7. * Treatment with intravenous thrombolysis or embolectomy prior to enrollment,
  8. * Clinical uncertainty about whether intracranial hemorrhage is present on the pre-enrollment head CT, and
  9. * 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.

Contacts and Locations

Study Contact

Alex Hall, BSN
CONTACT
404-778-1585
alex.hall@emory.edu
sara m keegan, MEd
CONTACT
513-584-0470
sara.stark@uc.edu

Principal Investigator

Jonathan Ratcliff, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady
Atlanta, Georgia, 30303
United States

Collaborators and Investigators

Sponsor: Sense Diagnostics, LLC

  • Jonathan Ratcliff, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-23
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2020-12-23
Study Completion Date2024-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Intracranial Hemorrhages
  • Traumatic Brain Injury