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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 below
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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 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

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 more

TUSC 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.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,261 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

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
Recent research and studies
~4 spots leftby Sep 2024