Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263023
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-02-05
Brief Title:
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
Sponsor:
34 Lives PBC
Organization:
34 Lives PBC
Study Overview
Official Title:
An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys
Status:
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:
OPTIMAL
Brief Summary:
This is a study to collect information to assess if transporting hard-to-place HTP donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals
Detailed Description:
This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion SNMP to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys
This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers Transplantation will follow standard-of-care at each transplant center including required post-transplant data collection which must be reported to the OPTN registry by the center
This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers Transplantation will follow standard-of-care at each transplant center including required post-transplant data collection which must be reported to the OPTN registry by the center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None