Status:
RECRUITING
Abdominal Wall Transplant
Lead Sponsor:
Duke University
Collaborating Sponsors:
Linda Cendales, MD
Kadiyala Ravindra, M.D.
Conditions:
Transplant;Failure,Kidney
Transplant; Failure, Liver
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation m...
Detailed Description
Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be foll...
Eligibility Criteria
Inclusion
- Candidates between 18-65 years old
- Willingness and legal ability to give consent
- Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke
Exclusion
- Malignancy at evaluation or history of malignancy that precludes transplantation
- Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.
- Medical exclusion criteria for general anesthesia
- Ongoing substance abuse or history of untreated substance abuse
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03310905
Start Date
May 1 2018
End Date
June 1 2028
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710