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
Active Not Recruiting

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

First listed
Jul 12, 2024
Start date
Nov 26, 2024
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 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 ]

Locations (29)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
Yale UniversityNew HavenConnecticut06511-
Baptist Medical Center - JacksonvilleJacksonvilleFlorida32207-
University of South FloridaTampaFlorida33606-
Northwestern UniversityChicagoIllinois60611-
Advocate Lutheran General HospitalPark RidgeIllinois60068-
Indiana UniversityIndianapolisIndiana46202-
University of Kansas Medical CenterKansas CityKansas66160-
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-
NYU Langone HealthNew YorkNew York10016-
Weill Cornell MedicineNew YorkNew York10065-
University of Rochester Medical CenterRochesterNew York14642-
Montefiore Medical CenterThe BronxNew York10467-
Cleveland ClinicClevelandOhio44195-
Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Rhode Island HospitalProvidenceRhode Island02903-
University of Texas Southwestern Medical CenterDallasTexas75390-
Virginia Commonwealth UniversityRichmondVirginia23298-

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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