Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06097845
Other study ID # 22-0873
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 27, 2023
Est. completion date August 1, 2026

Study information

Verified date October 2023
Source Northwell Health
Contact Netanel Ben-Shalom, MD
Phone 212-434-3900
Email nbenshalom@northwell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.


Description:

Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI & CT) in a prospective, quality control study.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 1, 2026
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Transcranial Ultrasound
Patients who underwent reconstructive sonolucent cranioplasty will receive standard of care postoperative imaging (i.e. CT, MRI) in addition to ultrasound imaging. Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices (GE Venue Go, Fujifilm Sonosite X-Porte, GE Volusion E10 and Clarius HD3 etc.) currently used in routine clinical practice.

Locations

Country Name City State
United States Lenox Hill Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of Neuroanatomy accuracy of TCUS Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound 12 months
Primary Diagnostic accuracy of TCUS Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04111562 - Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects N/A
Terminated NCT00923793 - Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty Phase 3
Completed NCT01641523 - Controlled Study in Cranioplasty Reconstruction N/A
Enrolling by invitation NCT05362370 - Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness