Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-09-22
Brief Title:
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion NMP to resuscitate moderately steatotic livers for transplantation in patients This will be a single-site clinical trial placing donor livers with 30-60 macrosteatosis on NMP and then transplanting those that meet commonly accepted viability criteria The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers further expanding the donor organ pool
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