Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Part of paid clinical trials in Los Angeles, California.

Sponsor
CereVasc Inc
Study ID
NCT06498960
Status
Recruiting
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Conditions

  • Normal Pressure Hydrocephalus

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CereVasc eShunt System — DEVICE
    The eShunt System consists of the following components: * eShunt Implant * eShunt Delivery Catheter and Transfer Tool * eShunt Anchor
  • VP Shunt — DEVICE
    Control arm - VP shunt

Study Details

Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.

Key Dates

Start date
Nov 26, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2031

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: eShunt System
    Endovascular placement of the eShunt Implant
  • Active Comparator: VP Shunt
    Surgical ventriculo-peritoneal shunt procedure

Primary Outcome Measure

Primary Effectiveness Endpoint [ Time Frame: 6 months ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
Yale UniversityNew HavenConnecticut06511
Lindsey Fraczkiewicz
[email protected]
Ryan Hebert, MD (PRINCIPAL_INVESTIGATOR)
Baptist Medical Center - JacksonvilleJacksonvilleFlorida32207
Jefferson Atillo, RN, BSN
[email protected]
Ricardo Hanel, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606-
Northwestern UniversityChicagoIllinois60611
Pouya Nazari
[email protected]
Matthew B. Potts, MD (PRINCIPAL_INVESTIGATOR)
Advocate Lutheran General HospitalPark RidgeIllinois60068-
Indiana UniversityIndianapolisIndiana46202-
University of Kansas Medical CenterKansas CityKansas66160
Max Hardenbrook
[email protected]
Koji Ebersole, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky Research FoundationLexingtonKentucky40506-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HealthWest BloomfieldMichigan48322-
Cooper Neurological InstituteCamdenNew Jersey08103-
Albany Medical CenterAlbanyNew York12208-
University at Buffalo NeurosurgeryBuffaloNew York14203-
Northwell HealthManhassetNew York11030-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Lenox Hill HospitalNew YorkNew York10075
Sara Massimo
[email protected]
Yafell Serulle, MD, PhD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Michelle Sclafani
[email protected]
Howard Riina, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Anna Angkatavanich
[email protected]
Srikanth Boddu, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642-
Montefiore Medical CenterThe BronxNew York10467-
Cleveland ClinicClevelandOhio44195
Joyce Barmen
[email protected]
Mark Bain, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Sha'Mere Herder
[email protected]
Pascal M Jabbour, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903-
University of Texas Southwestern Medical CenterDallasTexas75390-
Virginia Commonwealth UniversityRichmondVirginia23298
Amy Erickson
[email protected]
Mally Jones
[email protected]
John Reavey-Cantwell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
University of Southern California· Los Angeles, CAYale University· New Haven, CTBaptist Medical Center - Jacksonville· Jacksonville, FLUniversity of South Florida· Tampa, FLNorthwestern University· Chicago, ILAdvocate Lutheran General Hospital· Park Ridge, IL

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