RECRUITING

Access Cannulation Trial II

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-23
Study Completion:2027-03-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05490225

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Britnee Ochabski
CONTACT
9493224050
bochabski@voyagerbiomedical.com
Supraj Amunje
CONTACT
samunje@voyagerbiomedical.com

Principal Investigator

Stephen Hohmann, MD
PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health

Study Locations (Sites)

Trinity Research Group
Dothan, Alabama, 36301
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Fairlawn Surgery Center
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Voyager Biomedical

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-23
Study Completion Date2027-03-25

Study Record Updates

Study Start Date2025-04-23
Study Completion Date2027-03-25

Terms related to this study

Additional Relevant MeSH Terms

  • Dialysis; Complications
  • Vascular Access Complication