Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial for abdominal wall transplantation is investigating a new treatment option for patients who have problems with their abdominal wall, such as defects, hernias, or injuries. This surgery can help repair the abdominal area and may be performed alone or along with other organ transplants, like kidney, liver, or bowel transplants. The goal of the trial is to see how safe and effective this procedure is.
To participate in this study, candidates need to be between 18 and 65 years old and should be willing to give their consent for the procedure. They must also meet specific medical criteria to ensure they are good candidates for this type of transplant. It's important to note that women who could become pregnant must use reliable birth control for at least two years after the surgery, as the effects of pregnancy on the transplanted area are still unknown. Participants can expect careful monitoring throughout the trial to assess their recovery and the success of the transplant. Overall, this trial aims to improve treatment options for those with abdominal wall issues.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Patients applied
Trial Officials
Linda Cendales, MD
Principal Investigator
Duke University
Kadiyala Ravindra, MD
Principal Investigator
Duke University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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