← Back to Search

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
Must not have
Secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct, or venous infarct
Coagulopathy defined as INR > 1.4, elevated aPTT, or concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset, known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, platelet count < 100x103cells/mm3, or known platelet dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a surgery to remove a brain bleed using a special technique.
Select...
I have had a significant brain bleed above the cerebellum.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My brain bleed is due to a specific underlying condition like an aneurysm or tumor.
Select...
I have a bleeding disorder or am on blood thinners.
Select...
I have had a skull fracture with many pieces.
Select...
I have had osteomyelitis before.
Select...
I have had bleeding in the lower part of my brain.
Select...
I cannot give consent myself and no one can do it on my behalf.
Select...
I have had a tumor in my skull.
Select...
My condition involves the midbrain.
Select...
I do not have a fever over 100.7F or an open draining wound.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The presence of intracerebral hemorrhage
Secondary study objectives
Accuracy of TUSC to detect hydrocephalus
Accuracy of TUSC to detect intraventricular hemorrhage
Cost of TUSC
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
909 Previous Clinical Trials
542,135 Total Patients Enrolled
Christopher P. Kellner, MDPrincipal InvestigatorMount Sinai Health System Department of Neurosurgery

Media Library

ClearFit implant (Synthetic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05538286 — N/A
Transcranial Ultrasound Research Study Groups: transcranial ultrasonography through sonolucent cranioplasty
Transcranial Ultrasound Clinical Trial 2023: ClearFit implant Highlights & Side Effects. Trial Name: NCT05538286 — N/A
ClearFit implant (Synthetic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538286 — N/A
~8 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top