← Back to Search

Transcranial Ultrasound for Cranioplasty

N/A

Recruiting

Led By Netanel Ben-Shalom, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial studies the effects of ultrasound on the skull to treat brain injury. It's a real-world study, with open results.

Who is the study for?

This trial is for men and women aged 18 or older who are undergoing reconstructive sonolucent cranioplasty as standard care. Participants must be willing to follow study procedures and be available for the entire study duration. Pregnant individuals cannot participate.Check my eligibility

What is being tested?

The trial is observing how transcranial ultrasound works when used through a sonolucent (sound-transparent) material during cranioplasty, which is skull reconstruction surgery. It's an open-label study, meaning everyone knows what treatment they're getting.See study design

What are the potential side effects?

Since this trial focuses on observation of transcranial ultrasound in a surgical setting rather than testing a new drug, specific side effects related to medications are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a skull reconstruction with a transparent implant as part of my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Diagnostic accuracy of TCUS

Identification of Neuroanatomy accuracy of TCUS

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcranial UltrasoundExperimental Treatment1 Intervention

Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,993 Total Patients Enrolled

Netanel Ben-Shalom, MDPrincipal InvestigatorLenox Hill Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities still available to participate in this research?

"Affirmative. Clinicaltrials.gov has verified that this trial, listed on June 27th 2023, is currently accepting enrollees. There are 50 slots available at a single site."

Answered by AI

How many participants are presently engaged in this experiment?

"Affirmative. The evidence available on clinicaltrials.gov verifies that this trial, which was initially advertised on June 27th 2023, is still recruiting participants. Approximately 50 people are required to participate from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Ultrasound Via Sonolucent Cranioplasty

Netanel Ben-Shalom 2023. "Transcranial Ultrasound Via Sonolucent Cranioplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097845.