Abdominal Wall Transplant

NCT03310905 | Recruiting DMC

• 1 other identifier: Pro00084054
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 may be performed alone or in combination with another transplant.

Conditions

Transplant;Failure,Kidney; Transplant; Failure, Liver; Transplant; Failure, Bowel; Abdominal Wall Defect; Abdominal Wall Fistula; Abdominal Wall Hernia; Abdominal Wall Injury

Keywords

Research; Transplant; Abdominal Wall; Hernia

Outcome Measures

Primary Outcomes (1)

• Number of subjects with a viable abdominal wall transplant at 18 months

  up to 18 months

Study Arms (2)

Isolated Abdominal Wall Transplant

EXPERIMENTAL

Procedure: Abdominal Wall Transplant alone

Abdominal Wall with Solid Organ Transplant

EXPERIMENTAL

Procedure: Abdominal Wall Transplant with another solid organ transplant

Interventions

Abdominal Wall Transplant with another solid organ transplant PROCEDURE

Transplant of abdominal wall in combination with another solid organ transplant.

Abdominal Wall with Solid Organ Transplant

Abdominal Wall Transplant alone PROCEDURE

Abdominal Wall Transplant alone

Isolated Abdominal Wall Transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Ongoing substance abuse or history of untreated substance abuse

Sponsors & Collaborators

• Duke University: lead
• Linda Cendales, MD: collaborator
• Kadiyala Ravindra, M.D.: collaborator
• Detlev Erdmann, M.D.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Abdominal; Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda Cendales, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Kadiyala Ravindra, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Cendales, MD

CONTACT

919-681-7514; linda.cendales@duke.edu

Kadiyala Ravindra, MD

CONTACT

919-613-9687; kadiyala.ravindra@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: May 1, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)