Access Cannulation Trial II

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Voyager Biomedical
Study ID
NCT05490225
Status
Recruiting
Apply to this trial

Conditions

  • Dialysis; Complications
  • Vascular Access Complication

Eligibility Criteria

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

Interventions

  • VenaSure — DEVICE
    The device will be surgically implanted at the access site in subjects undergoing routine hemodialysis. The device is expected to provide a target to aid in long-term cannulation success.

Study Details

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

Key Dates

Start date
Apr 23, 2025
Status verified
Oct 2025
Primary completion
Mar 25, 2027
Completion
Mar 25, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ark Implantation
    Single arm study. Depending on the clinical needs of the patient, the physician will decide if a single return device is needed (ex. easily cannulatable arterial pull site but the venous return access site is poorly accessible for cannulation) or two devices (both arterial pull and venous return are poorly accessible for cannulation).

Primary Outcome Measure

To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis. [ Time Frame: 6 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Trinity Research GroupDothanAlabama36301
Emily Ivey Director
[email protected]
334-456-5511
Jason Beaver, MD (PRINCIPAL_INVESTIGATOR)
Apex ResearchRiversideCalifornia92505
Karina Trejo
[email protected]
951-529-4708
Dalia Dawoud, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Danielle Montano CRC
[email protected]
617-525-8555
Mohamed Hussain, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthHyde ParkNew York11042
Yana Etkin, MD
[email protected]
(516) 233-3701
Victoria Wairimu
[email protected]
(516) 233-3701
MUSC Health OrangeburgOrangeburgSouth Carolina29118
Kristen Covington
[email protected]
(803) 395-2021
Mark London, MD (PRINCIPAL_INVESTIGATOR)
Cardiothoracic and Vascular SurgeonsAustinTexas78756
Shir Yelovitch, PhD
[email protected]
512-459-8753
Adam Turley, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & WhiteDallasTexas75246
Rehma Shabbir
[email protected]
214-820-1722
Stephen Hohmann, MD (PRINCIPAL_INVESTIGATOR)
Fairlawn Surgery CenterRoanokeVirginia24014
Aleisha Umber Director
[email protected]
540-904-6170
Ryan Evans, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dothan, AL

By research site
Trinity Research Group· Dothan, ALApex Research· Riverside, CABrigham and Women's Hospital· Boston, MANorthwell Health· Hyde Park, NYMUSC Health Orangeburg· Orangeburg, SCCardiothoracic and Vascular Surgeons· Austin, TX

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