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Synthetic Implant
Transcranial Ultrasound for Stroke (TUSC MIS Trial)
N/A
Recruiting
Led By Christopher P. Kellner, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing minimally invasive intracerebral hemorrhage evacuation with sonolucent cranioplasty or hemicraniectomy with sonolucent cranioplasty
Presence of spontaneous supratentorial ICH ≥20 mL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
TUSC MIS Trial Summary
This trial will test whether transcranial ultrasound can detect and quantify postoperative intracerebral hemorrhage (ICH) better than computed tomography (CT).
Who is the study for?
This trial is for adults over 18 who've had a stroke leading to bleeding in the brain, are undergoing a specific minimally invasive surgery with sonolucent cranioplasty, and have certain scores on stroke severity scales. Excluded are those with skull fractures, other causes of bleeding, coagulation issues, active infections or substance abuse problems.Check my eligibility
What is being tested?
The study tests if transcranial ultrasound through a transparent implant can effectively monitor post-surgery bleeding in the brain. It compares this method's ability to detect and measure blood against standard CT scans which are more costly and physically demanding.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort from wearing the ultrasound device or risks associated with surgical implantation of the sonolucent cranioplasty.
TUSC MIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a surgery to remove a brain bleed using a special technique.
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I have had a significant brain bleed above the cerebellum.
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I am 18 years old or older.
TUSC MIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The presence of intracerebral hemorrhage
Secondary outcome measures
Accuracy of TUSC to detect hydrocephalus
Accuracy of TUSC to detect intraventricular hemorrhage
Cost of TUSC
+4 moreTUSC MIS Trial Design
1Treatment groups
Experimental Treatment
Group I: transcranial ultrasonography through sonolucent cranioplastyExperimental Treatment2 Interventions
All surgical procedures and implants in this protocol are standard of care.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,451 Total Patients Enrolled
Christopher P. Kellner, MDPrincipal InvestigatorMount Sinai Health System Department of Neurosurgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another health condition that may make it hard for you to stay healthy for the duration of the study.My brain bleed is due to a specific underlying condition like an aneurysm or tumor.I have a bleeding disorder or am on blood thinners.I am having a surgery to remove a brain bleed using a special technique.You have a "do not resuscitate" or "do not intubate" order in place.I have had a skull fracture with many pieces.I have had osteomyelitis before.I have had bleeding in the lower part of my brain.I cannot give consent myself and no one can do it on my behalf.I am unable or unwilling to follow the study's schedule according to my doctor.Your National Institute of Health Stroke Scale (NIHSS) score is 6 or higher.I have had a significant brain bleed above the cerebellum.You have a Glasgow Coma Scale (GCS) score between 5 and 15 when you first come in for the study.I am 18 years old or older.I have had a tumor in my skull.My condition involves the midbrain.I do not have a fever over 100.7F or an open draining wound.
Research Study Groups:
This trial has the following groups:- Group 1: transcranial ultrasonography through sonolucent cranioplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in the research project?
"Confirmed. On clinicaltrials.gov, it is clear that this experiment is now actively recruiting participants; the trial was first listed on September 9th 2022 and recently updated on September 8th 2022. The study requires 25 individuals to be enrolled at a single location."
Answered by AI
Is it still possible to enrol in this research project?
"On clinicaltrials.gov, it is confirmed that this medical trial was posted on September 9th 2022 and last updated a day later. The study is actively seeking participants at the moment."
Answered by AI
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