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Studies

Interventional Recruiting

NCT05490225 on ClinicalTrials.gov

Access Cannulation Trial II

Official title: A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)

  • Sponsor: Voyager Biomedical
  • Enrollment: 100 (Estimated)
  • Study start: 2025-04-23 (Actual)
  • Primary completion: 2027-03-25 (Estimated)
  • Study completion: 2027-03-25 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: This is a pivotal, interventional, prospective, single arm, open-label study.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Dialysis; Complications
  • Vascular Access Complication

Intervention / Treatment

  • Device: VenaSure

Primary Outcome Measures

  • To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis. (6 months)
    Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.
  • To evaluate the safety of the study device. (12 months)
    The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, complicated seroma) during a 12- month follow-up period from initial implantation adjudicated by a Data Monitoring Committee (DMC)

Countries

United States

Locations and Investigators

  • Trinity Research Group, Dothan, United States (Recruiting)
    • Emily Ivey Director
    • Jason Beaver, MD (Principal Investigator)
  • Apex Research, Riverside, United States (Recruiting)
    • Karina Trejo
    • Dalia Dawoud, MD (Principal Investigator)
  • Brigham and Women's Hospital, Boston, United States (Recruiting)
    • Danielle Montano CRC
    • Mohamed Hussain, MD (Principal Investigator)
  • Northwell Health, Hyde Park, United States (Recruiting)
    • Yana Etkin, MD
    • Victoria Wairimu
  • MUSC Health Orangeburg, Orangeburg, United States (Recruiting)
    • Kristen Covington
    • Mark London, MD (Principal Investigator)
  • Cardiothoracic and Vascular Surgeons, Austin, United States (Recruiting)
    • Shir Yelovitch, PhD
    • Adam Turley, MD (Principal Investigator)
  • Baylor Scott & White, Dallas, United States (Recruiting)
  • Fairlawn Surgery Center, Roanoke, United States (Recruiting)
    • Aleisha Umber Director
    • Ryan Evans, MD (Principal Investigator)

Study Officials