Using ultrasound through transparent skull implants for brain imaging
Transcranial Ultrasound Via Sonolucent Cranioplasty
This study is testing if using ultrasound through clear skull implants can provide a safer and easier way to take brain images for patients who have had cranial surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06097845 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of transcranial ultrasound via sonolucent cranioplasty to provide a non-invasive imaging alternative for patients undergoing cranial reconstruction. By utilizing transparent polymethyl methacrylate (PMMA) materials, the study aims to overcome the limitations of traditional imaging techniques like CT and MRI, which can be burdensome and invasive. The research will collect real-world evidence on the feasibility and efficacy of this innovative approach compared to standard imaging modalities. The study is observational and open-label, focusing on patients who have already received cranioplasty as part of their treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing reconstructive sonolucent cranioplasty.
Not a fit: Patients who are pregnant will not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risks and costs associated with traditional imaging methods for patients undergoing cranial procedures.
How similar studies have performed: While the technique is novel and limited published data exists, early results have shown promise in using transcranial ultrasound through sonolucent cranial plates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care. 4. Male or female, aged ≥ 18. Exclusion Criteria: 1\. Patients who are pregnant
Where this trial is running
New York, New York
- Lenox Hill Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Netanel Ben-Shalom, MD — Lenox Hill Hospital
- Study coordinator: Netanel Ben-Shalom, MD
- Email: nbenshalom@northwell.edu
- Phone: 212-434-3900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.