Cleveland Clinic
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Location contact
Choon Hyuck D Kwon, MD, PhD
PRINCIPAL_INVESTIGATOR
Erlind Allkushi
CONTACT
Mary Bilancini
CONTACT
NCT Number: NCT07102550
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Choon Hyuck D Kwon, MD, PhD
PRINCIPAL_INVESTIGATOR
Erlind Allkushi
CONTACT
Mary Bilancini
CONTACT
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:
Participants will:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.
Time frame: 1 year post living donor liver transplant
Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.
Time frame: 1 year post living donor liver transplant
Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection
Time frame: From date of transplant until date of discharge from hospital, assessed up to 365 days
Hospital length of stay
Time frame: From date of transplant until date of transfer out of ICU, assessed up to 365 days
ICU length of stay (days)
Time frame: 1 year post living donor liver transplant
Number of readmissions post-operatively
Contact information is provided by the study sponsor or research team.
Erlind Allkushi
CONTACT
Mary Bilancini
CONTACT
Choon Hyuck David Kwon
Other
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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