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NCT05538286 · ClinicalTrials.gov registry record · NA
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
A NA study of Transcranial Ultrasound With Sonolucent Cranioplasty and TUSC, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05538286: Recruiting NA study of Transcranial Ultrasound With Sonolucent Cranioplasty and TUSC, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05538286 is a NA study of Transcranial Ultrasound With Sonolucent Cranioplasty and TUSC that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05538286, a NA study of Transcranial Ultrasound With Sonolucent Cranioplasty and TUSC, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires significant physical and financial costs. Studies have demonstrated varying degrees of efficacy when using transcranial ultrasound to measure ICH volume. Recently, synthetic implants for cranioplasty have been shown to be safe and sonolucent. This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH patients.
Primary Outcome
Accuracy of TUSC via ClearFit to detect the presence or absence of postoperative intracerebral hemorrhage compared to CT.
Conditions Studied
Interventions
- DEVICE ClearFit implant
- PROCEDURE transcranial ultrasonography through sonolucent cranioplasty
Study Locations (1)
New York
- Mount Sinai Health System - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-09-23 |
| Est. Completion | 2025-09 |
| Phase | NA |
What NCT05538286 shows while recruiting
NCT05538286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Transcranial Ultrasound With Sonolucent Cranioplasty appearing as the primary indexed condition, and to 2 interventions - of which ClearFit implant is the first listed.
NCT05538286 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05538286 about?
NCT05538286 is a clinical study titled "Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation". Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires significant physical and financial costs. Studies have demonstrated varying degre...
What is the current status of trial NCT05538286?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2022-09-23. Estimated completion is 2025-09.
What conditions does trial NCT05538286 study?
This clinical trial studies the following conditions: Transcranial Ultrasound With Sonolucent Cranioplasty, TUSC.
What interventions are being tested in trial NCT05538286?
The interventions under investigation include: ClearFit implant (DEVICE), transcranial ultrasonography through sonolucent cranioplasty (PROCEDURE).
Who is sponsoring clinical trial NCT05538286?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05538286 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05538286's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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