Surgery study: Neuralert Monitor
Official title Neuralert Stroke Monitor Trial
ClinicalTrials.gov ID: NCT07362303
What this study is testing
- What it's testing
- This study checks if the device is safe and works well. It aims to show the device gives fewer than 2 false alarms per day and detects stroke better than a random alert system.
- Who it's for
- People who have had surgery and are at risk for stroke.
- What's involved
- Participants will wear a non-invasive monitor on each wrist. The device continuously watches for signs of stroke by checking for uneven movement in the arms.
- Time commitment
- The source text does not specify the total duration or number of visits required.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- (all must be yes)
- Male or female age ≥ 22 years
- Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
- Intracardiac surgical or endovascular procedures, including valve replacement
- Ascending aorta or aortic arch surgical or endovascular repair
You likely can't join if
- (all must be no)
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation...
- Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity...
- Above the wrist amputation
- Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
- Currently imprisoned
See the full eligibility criteria
- (all must be yes)
- Male or female age ≥ 22 years
- Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
- Intracardiac surgical or endovascular procedures, including valve replacement
- Ascending aorta or aortic arch surgical or endovascular repair
- Open surgical or endovascular carotid revascularization
- Age ≥ 80 years
- Prior stroke/ transient ischemic attack (TIA)
- Hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation
- Severely reduced left ventricular cardiac ejection fraction (i.e., \<30%) or anterior left ventricular wall akinesis
- Atrial fibrillation
- (all must be no)
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity motor score between the two arms of \>0
- Above the wrist amputation
- Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
- Currently imprisoned
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.