RecruitingPhase 2NCT07102550

Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial


Sponsor

Choon Hyuck David Kwon

Enrollment

40 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adults >/= 18 years old
  • Recipient of LDLT

Exclusion Criteria6

  • Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee.
  • Patients < 18 years old
  • Patients who cannot provide informed consent
  • Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT)
  • Patients who do not wish to participate
  • Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable populations and will, therefore, be excluded from participation.

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Interventions

BIOLOGICALMiMedx AmnioFix

MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT07102550


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