Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422871
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
PReSeRVE-HD Observational Study of the Merit HeRO Graft and Super HeRO in Patients on Hemodialysis
Sponsor:
Merit Medical Systems Inc
Organization:
Merit Medical Systems Inc
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PReSeRVE-HD
Brief Summary:
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medicals 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 Patients in the study will return to their study center 4 times over 2 years for follow-up visits to check their current health and dialysis status
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None