RECRUITING

PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

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

The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.

Official Title

PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis

Quick Facts

Study Start:2025-05-30
Study Completion:2028-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06422871

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. * Subject provides written informed consent
  2. * Subject is ≥ 18 years
  3. * Subject is end-stage renal disease patient on hemodialysis.
  4. * Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)
  1. * Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
  2. * Subject has a topical or subcutaneous infection associated with the implantation site
  3. * Subject has known or suspected systemic infection, bacteremia or septicemia

Contacts and Locations

Study Contact

Hannah Susmeyer
CONTACT
978-758-6166
Hannah.Susmeyer@merit.com
Vicky Brunk, RN
CONTACT
717-873-3309
Vicky.Brunk@merit.com

Principal Investigator

Stephen Hohmann, MD
PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health

Study Locations (Sites)

Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, 75226
United States

Collaborators and Investigators

Sponsor: Merit Medical Systems, Inc.

  • 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 Date2025-05-30
Study Completion Date2028-10-30

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2028-10-30

Terms related to this study

Keywords Provided by Researchers

  • HeRO

Additional Relevant MeSH Terms

  • End Stage Renal Disease
  • Hemodialysis Access Failure