Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 4:25 PM
Study NCT ID:
NCT07102550
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2024-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
Sponsor:
Choon Hyuck David Kwon
Organization:
Study Overview
Official Title:
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-07
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:
None
Brief Summary:
The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults.
Detailed Description:
The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults. MiMedx placental tissue grafts are registered with the FDA for homologous use in any location in the body as a protective barrier that supports the healing cascade, which is the use the investigators intend it for in this trial.
The main questions this study aims to answer are:
1. Can bile-duct reinforcement using MiMedx placental tissue grafting demonstrate equal-to-improved biliary complications in patients who are recipients of living donor liver transplant?
2. What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?
Participants will:
1. undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.
2. consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.
3. consent to allow the study team to perform a review of their medial records after each standard-of-care follow-up visit to assess presence of any biliary complications up to 1 year post-transplant.
The main questions this study aims to answer are:
1. Can bile-duct reinforcement using MiMedx placental tissue grafting demonstrate equal-to-improved biliary complications in patients who are recipients of living donor liver transplant?
2. What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?
Participants will:
1. undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.
2. consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.
3. consent to allow the study team to perform a review of their medial records after each standard-of-care follow-up visit to assess presence of any biliary complications up to 1 year post-transplant.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: