Access Cannulation Trial II

Description

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

Study Overview

Study Details

Study overview

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.

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

Access Cannulation Trial II

Condition
Dialysis; Complications
Intervention / Treatment

-

Contacts and Locations

Dothan

Trinity Research Group, Dothan, Alabama, United States, 36301

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Roanoke

Fairlawn Surgery Center, Roanoke, Virginia, United States, 24014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Voyager Biomedical,

    Stephen Hohmann, MD, PRINCIPAL_INVESTIGATOR, Baylor Scott and White Health

    Study Record Dates

    2027-03-25