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

Primary Purpose

Hydrocephalus, Normal Pressure, Hydrocephalus

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

eShunt Implant

About this trial

This is an interventional treatment trial for Hydrocephalus, Normal Pressure focused on measuring eShunt, Minimally invasive shunt, Endovascular shunt

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation
Patient or legally authorized representative is able and willing to provide written informed consent
History or evidence of gait impairment duration ≥6 months
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 ≥10 cmH2O
4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
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:

Unable to walk 10 meters (33 feet) with or without an assistive device
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
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
Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
Unwilling or unable to comply with follow-up requirements

Sites / Locations

Yale UniversityRecruiting
University at Buffalo,Recruiting
NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

The Treatment Arm receives the eShunt Implant.

Outcomes

Primary Outcome Measures

Device and/or procedure-related serious adverse events (SAEs)

Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Secondary Outcome Measures

Number of participants with abnormal MRI findings

Number of participants with abnormal MRI findings and descriptive summaries of findings

Number of participants with abnormal CT findings

Number of participants with abnormal CT findings and descriptive summaries of findings

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

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

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

Number of participants with adverse events

Tabulation of all adverse events

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))

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))

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))

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))

Full Information

NCT ID

NCT05232838

First Posted

January 6, 2022

Last Updated

July 7, 2023

Sponsor

CereVasc Inc

Collaborators

AlvaMed, Inc., Simplified Clinical Data Systems, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05232838

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CereVasc Inc

Collaborators

AlvaMed, Inc., Simplified Clinical Data Systems, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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 10 subjects will receive the eShunt Implant at up to three investigational sites. It is anticipated that up to 45 patients may need to be enrolled (consented) in order to result in 10 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydrocephalus, Normal Pressure, Hydrocephalus

Keywords

eShunt, Minimally invasive shunt, Endovascular shunt

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

The Treatment Arm receives the eShunt Implant.

Intervention Type

Device

Intervention Name(s)

eShunt Implant

Intervention Description

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.

Primary Outcome Measure Information:

Title

Device and/or procedure-related serious adverse events (SAEs)

Description

Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Time Frame

90 days following eShunt Implant deployment

Secondary Outcome Measure Information:

Title

Number of participants with abnormal MRI findings

Description

Number of participants with abnormal MRI findings and descriptive summaries of findings

Time Frame

90 days following eShunt Implant deployment

Title

Number of participants with abnormal CT findings

Description

Number of participants with abnormal CT findings and descriptive summaries of findings

Time Frame

90 days following eShunt Implant deployment

Title

Number of participants with clinically significant abnormal complete blood count (CBC) results

Description

Number of participants with clinically significant abnormal results and descriptive summaries of CBC results

Time Frame

90, 180, and 365 days following eShunt Implant deployment

Title

Number of participants with clinically significant abnormal blood chemistry results

Description

Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results

Time Frame

90, 180, and 365 days following eShunt Implant deployment

Title

Number of participants with clinically significant abnormal neurological exam findings

Description

Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam findings

Time Frame

90, 180, and 365 days following eShunt Implant deployment and at study completion

Title

Number of participants with adverse events

Description

Tabulation of all adverse events

Time Frame

90, 180 and 365 days following eShunt Implant deployment and at study completion

Title

Change in gait compared to baseline

Description

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))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Change in cognitive ability compared to baseline

Description

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))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Change in urinary symptoms compared to baseline

Description

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))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Change in Modified Rankin Scale compared to baseline

Description

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))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation Patient or legally authorized representative is able and willing to provide written informed consent History or evidence of gait impairment duration ≥6 months 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: Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) and the absence of severe hippocampal atrophy Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20% CSF opening pressure ≥10 cmH2O Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 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: Unable to walk 10 meters (33 feet) with or without an assistive device 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 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 Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation Unwilling or unable to comply with follow-up requirements

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ona Whelove

Phone

4155152885

clinicaltrials@cerevasc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Travis Carbonneau

traviscarbonneau@cerevasc.com

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsey Fraczkiewicz

Phone

203-785-3490

lindsey.fraczkiewicz@yale.edu

First Name & Middle Initial & Last Name & Degree

Liz Brown

elizabeth.brown@yale.edu

First Name & Middle Initial & Last Name & Degree

Charles Matouk, MD

Facility Name

University at Buffalo,

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Gay

jgay@ubns.com

First Name & Middle Initial & Last Name & Degree

Adnan Siddiqui, MD, PhD

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cathryn Lapierre

Phone

646-501-2762

cathryn.lapierre@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Howard Riina, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30626626

Citation

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.

Results Reference

background

PubMed Identifier

34862267

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.

Results Reference

background

PubMed Identifier

24518764

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.

Results Reference

background

PubMed Identifier

32196732

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.

Results Reference

background

PubMed Identifier

15817019

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.

Results Reference

background

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

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