Hydrocephalus Clinical Trial
Official title:
US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus
Verified date | February 2024 |
Source | CereVasc Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly invasive, neuro-interventional procedure. The eShunt® Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
Status | Terminated |
Enrollment | 4 |
Est. completion date | September 15, 2023 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Patient is = 21 years old - Patient or legally authorized representative is able and willing to provide written informed consent - Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place for at least 7 days with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as: 1. Post-clamping ICP of > 20 cmH2O for 15 minutes, or 2. Post-clamping ICP > 25 cmH2O for < 15 minutes with patient intolerance to EVD clamping, or 3. Significant radiographic signs of increasing ventriculomegaly, or 4. Neurological decline attributable to ventriculomegaly and requiring CSF diversion - Clinical signs and symptoms of communicating hydrocephalus - Neurologically stable without evidence of severe vasospasm - Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by subject screening committee (SSC) - Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC Exclusion Criteria: - Presence of gross blood in CSF - Signs or symptoms of obstructive hydrocephalus - Active systemic infection or infection detected in CSF - Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus - Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available - Occlusion or stenosis of the internal jugular vein - Venous distension in the neck on physical exam - Medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arterial venous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain - Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram - History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency - Stroke or transient ischemic attack within 180 days of eShunt Procedure - Presence of a deep vein thrombosis superior to the popliteal vein - International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds) - Presence of a posterior fossa tumor or mass - Life expectancy < 1 year - Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up - Pregnant - Unwilling or unable to comply with follow-up requirements |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
United States | Montefiore Medical Center Department of Neurosurgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
CereVasc Inc | AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC |
United States,
Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9. — View Citation
Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in ICP | At 24 to 48 hours after eShunt Implant deployment (with EVD remaining clamped) an ICP measurement that indicates:
ICP below 20 cmH2O with no periods longer than 15 minutes above 20 cmH2O No episodes of ICP above 25 cmH2O with associated symptoms |
24-48 hours after eShunt Implant placement | |
Secondary | Occurrence of Serious Adverse Events | The number of device and/or procedure-related serious adverse events (SAEs) after the implant procedure will be calculated. | 90 days post procedure | |
Secondary | Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline. | Clinically significant changes from baseline CT images will be summarized | 1 year post procedure | |
Secondary | Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline | Clinically significant changes from baseline physical examination and neurologic examination assessments will be summarized | 1 year post procedure | |
Secondary | Summary of Adverse Events | Tabulation of all Adverse Events collected in the study. | 90 days post procedure and at study completion | |
Secondary | Changes in Modified Rankin Scale Scores | Changes in Modified Rankin Scale scores from baseline will be summarized. | 1 year post procedure | |
Secondary | Number of subjects requiring conversion to conventional CSF shunt | Evaluate the need for CSF diversion by conventional CSF shunt insertion within 12 months after eShunt Implant deployment | 1 year post procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06040697 -
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
|
||
Terminated |
NCT02408757 -
Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
|
||
Terminated |
NCT01863381 -
Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement
|
N/A | |
Completed |
NCT00652470 -
A Study Comparing Two Treatments for Infants With Hydrocephalus
|
Phase 2 | |
Completed |
NCT00196196 -
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
|
Phase 3 | |
Active, not recruiting |
NCT05068128 -
Combined Flow and Pressure Study of Craniospinal Dynamic
|
||
Completed |
NCT04496414 -
Bactiseal Catheter Safety Registry in China
|
||
Terminated |
NCT02900222 -
Study of Choroid Plexus Cauterization in Patients With Hydrocephalus
|
N/A | |
Recruiting |
NCT04099823 -
MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
|
N/A | |
Unknown status |
NCT02775136 -
An Evaluation of a Non-invasive Brain Monitor
|
N/A | |
Completed |
NCT00692744 -
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
|
N/A | |
Recruiting |
NCT04758611 -
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
|
N/A | |
Completed |
NCT03595033 -
Hydrocephalus iPad-App Based Intervention Study
|
N/A | |
Completed |
NCT04207229 -
CERTAS Programmable Valve Registry
|
||
Completed |
NCT01976559 -
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
|
N/A | |
Terminated |
NCT01973764 -
Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System
|
N/A | |
Completed |
NCT02381977 -
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
|
N/A | |
Recruiting |
NCT06086561 -
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
|
N/A | |
Recruiting |
NCT05910944 -
European Study of Prodromal iNPH
|
||
Recruiting |
NCT03650101 -
Improving Infant Hydrocephalus Outcomes in Uganda
|