An observational study in End Stage Renal Disease and Hemodialysis Access Failure, sponsored by Merit Medical Systems, Inc.. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Merit Medical Systems, Inc. · Observational
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Merit Medical Systems, Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
End-stage renal disease patients on hemodialysis who have exhausted all other access options.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device.
Device: HeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.
Composite Endpoint
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
Time frame: 6 months
Clinical Success
Time frame: 12 and 24 months
Proportion of subjects with primary patency
Time frame: 6, 12 and 24 months
Proportion of subjects with cumulative patency
Time frame: 6, 12, and 24 months
Device-related safety events
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jun 2027, 23 months after the start.
Of 150 observational studies under Kidney Failure, Chronic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.