[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06097845":3,"trial-entities:NCT06097845":93,"trial-summary:NCT06097845":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":37,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":85,"overall_officials":88,"references":91,"see_also_links":92},"NCT06097845","22-0873","Transcranial Ultrasound Via Sonolucent Cranioplasty","RECRUITING","2028-12-31","2025-09","2025-09-15","2023-06-27","Northwell Health","OTHER",false,"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.","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.",[18,19,20],"Cranioplasty","Sonolucent Cranioplasty","Reconstructive Cranioplasty",[22,23,24],"Transcranial Ultrasound","SOC ultrasound","PMMA implant","INTERVENTIONAL","DIAGNOSTIC",[28],"NA",{"count":30,"type":31},50,"ESTIMATED",[33],{"type":34,"name":22,"description":35,"armGroupLabels":36},"DIAGNOSTIC_TEST","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.",[22],[38,42],{"measure":39,"description":40,"timeFrame":41},"Identification of Neuroanatomy accuracy of TCUS","Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound","12 months",{"measure":43,"description":44,"timeFrame":41},"Diagnostic accuracy of TCUS","Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound",[],"ALL","18 Years",null,{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.\n4. Male or female, aged ≥ 18.\n\nExclusion Criteria:\n\n1\\. Patients who are pregnant",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":58,"status":7,"city":59,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":82},"Lenox Hill Hospital","New York","10075","United States",[63,68,72,75,77,79,81],{"name":64,"role":65,"phone":66,"email":67},"Netanel Ben-Shalom, MD","CONTACT","212-434-3900","nbenshalom@northwell.edu",{"name":69,"role":65,"phone":70,"email":71},"Tamika Wong, MPH","212-434-4836","twong4@northwell.edu",{"name":73,"role":74},"Randy D'Amico, MD","SUB_INVESTIGATOR",{"name":76,"role":74},"Heustein Sy, MD",{"name":78,"role":74},"Vadim Zhigin, PA",{"name":80,"role":74},"Olivia Albers, NP",{"name":69,"role":74},{"lat":83,"lon":84},40.71427,-74.00597,[86,87],{"name":64,"role":65,"phone":66,"email":67},{"name":69,"role":65,"phone":70,"email":71},[89],{"name":64,"affiliation":58,"role":90},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":94,"biomarkers":95},[18],[],{"nct_id":4,"found":97,"summary":98,"prompt_version":108},true,{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is a single-arm, observational study, meaning all 50 participants will receive the same intervention. It is also open-label, so both you and the study team will know you are receiving the transcranial ultrasound.","completed","Transcranial Ultrasound via Sonolucent Cranioplasty Study","This study is looking at a new way to image the brain using Transcranial Ultrasound (TCUS) through a special type of skull implant called a sonolucent cranioplasty. This new ultrasound method could be a safer and more convenient option compared to standard imaging like CT scans and MRIs. Researchers want to see how accurately TCUS can identify brain structures and diagnose conditions, compared to these traditional methods. You might be able to join if you are an adult (18 or older) who is already scheduled to have a reconstructive sonolucent cranioplasty. The study aims to enroll 50 participants.","The study will measure outcomes related to the ultrasound's accuracy at 12 months.",98,"You will receive standard postoperative imaging (CT, MRI) in addition to ultrasound imaging performed by clinicians using FDA-approved ultrasound devices.","Not stated in the trial record.",[22],"v2"]