US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Hydrocephalus Clinical Trial

Official title:

US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232838
• Other study ID #: CLIN-0016
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: October 30, 2029

Study information

• Verified date: April 2024
• Source: CereVasc Inc
• Contact: Ona Whelove
• Phone: 4155152885
• Email: clinicaltrials[@]cerevasc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.

Description:

This is a prospective, non-randomized, open-label, multi-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional cerebrospinal fluid (CSF) shunt implant is indicated.

Up to 30 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 150 patients may need to be enrolled (consented) in order to result in 30 subjects who qualify according to the inclusion/exclusion criteria. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months until the study is closed or up to five years post-implantation.

The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2029
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation

2. Patient or legally authorized representative is able and willing to provide written informed consent

3. History or evidence of gait impairment duration =6 months

4. Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:

1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) and the absence of severe hippocampal atrophy

2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%

3. CSF opening pressure =8 cmH2O

4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score =12

5. 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)

6. 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:

1. Unable to walk 10 meters (33 feet) with or without an assistive device

2. Signs or symptoms of obstructive hydrocephalus

3. Active systemic infection or infection detected in CSF

4. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus

5. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available

6. Occlusion or stenosis of the internal jugular vein

7. Venous distension in the neck on physical exam

8. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram

9. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency

10. Stroke or transient ischemic attack within 180 days of eShunt Procedure

11. Presence of a deep vein thrombosis superior to the popliteal vein

12. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)

13. Presence of a posterior fossa tumor or mass

14. Life expectancy < 1 year

15. Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up

16. Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation

17. Unwilling or unable to comply with follow-up requirements

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure

Intervention

Device:
• eShunt Implant
The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University at Buffalo,	Buffalo	New York
United States	Baptist Health	Jacksonville	Florida
United States	University of Kentucky Research Foundation	Lexington	Kentucky
United States	Yale University	New Haven	Connecticut
United States	NYU Langone Health	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
CereVasc Inc	AlvaMed, Inc., Simplified Clinical Data Systems, LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

Welk B, Lenherr S, Elliott S, Stoffel J, Gomes CM, de Bessa J, Cintra LKL, Myers JB; Neurogenic Bladder Research Group. The creation and validation of a short form of the Neurogenic Bladder Symptom Score. Neurourol Urodyn. 2020 Apr;39(4):1162-1169. doi: 10.1002/nau.24336. Epub 2020 Mar 20. — View Citation

Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device and/or procedure-related serious adverse events (SAEs)	Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)	90 days following eShunt Implant deployment
Secondary	Number of participants with abnormal MRI findings	Number of participants with abnormal MRI findings and descriptive summaries of findings	90 days following eShunt Implant deployment
Secondary	Number of participants with abnormal CT findings	Number of participants with abnormal CT findings and descriptive summaries of findings	90 days following eShunt Implant deployment
Secondary	Number of participants with clinically significant abnormal complete blood count (CBC) results	Number of participants with clinically significant abnormal results and descriptive summaries of CBC results	90, 180, and 365 days following eShunt Implant deployment
Secondary	Number of participants with clinically significant abnormal blood chemistry results	Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results	90, 180, and 365 days following eShunt Implant deployment
Secondary	Number of participants with clinically significant abnormal neurological exam findings	Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam findings	90, 180, and 365 days following eShunt Implant deployment and at study completion
Secondary	Number of participants with adverse events	Tabulation of all adverse events	90, 180 and 365 days following eShunt Implant deployment and at study completion
Secondary	Change in gait compared to baseline	Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility))	90, 180 and 365 days following eShunt Implant deployment
Secondary	Change in cognitive ability compared to baseline	Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability))	90, 180 and 365 days following eShunt Implant deployment
Secondary	Change in urinary symptoms compared to baseline	Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms))	90, 180 and 365 days following eShunt Implant deployment
Secondary	Change in Modified Rankin Scale compared to baseline	Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability))	90, 180 and 365 days following eShunt Implant deployment