NCT06422871 PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
| NCT ID | NCT06422871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Merit Medical Systems, Inc. |
| Condition | End Stage Renal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-28 |
| Primary Completion | 2027-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-07-28 with a primary completion date of 2027-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: * Subject provides written informed consent * Subject is ≥ 18 years * Subject is end-stage renal disease patient on hemodialysis. * Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU) Key Exclusion Criteria: * Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement * Subject has a topical or subcutaneous infection associated with the implantation site * Subject has known or suspected systemic infection, bacteremia or septicemia
Contact & Investigator
Stephen Hohmann, MD
PRINCIPAL INVESTIGATOR
Baylor Scott and White Health
Frequently Asked Questions
Who can join the NCT06422871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06422871 currently recruiting?
Yes, NCT06422871 is actively recruiting participants. Contact the research team at Hannah.Susmeyer@merit.com for enrollment information.
Where is the NCT06422871 trial being conducted?
This trial is being conducted at Washington D.C., United States, Sarasota, United States, Raleigh, United States, Pittsburgh, United States and 3 additional locations.
Who is sponsoring the NCT06422871 clinical trial?
NCT06422871 is sponsored by Merit Medical Systems, Inc.. The principal investigator is Stephen Hohmann, MD at Baylor Scott and White Health. The trial plans to enroll 100 participants.