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Abdominal Wall Transplant

Primary Purpose

Transplant;Failure,Kidney, Transplant; Failure, Liver, Transplant; Failure, Bowel

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Abdominal Wall Transplant with another solid organ transplant

Abdominal Wall Transplant alone

About this trial

This is an interventional treatment trial for Transplant;Failure,Kidney focused on measuring Research, Transplant, Abdominal Wall, Hernia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Isolated Abdominal Wall Transplant

Abdominal Wall with Solid Organ Transplant

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03310905

First Posted

October 11, 2017

Last Updated

January 24, 2023

Sponsor

Duke University

Collaborators

Linda Cendales, MD, Kadiyala Ravindra, M.D., Detlev Erdmann, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT03310905

Brief Title

Abdominal Wall Transplant

Official Title

Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

January 1, 2028 (Anticipated)

Study Completion Date

June 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Linda Cendales, MD, Kadiyala Ravindra, M.D., Detlev Erdmann, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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 followed for a study period of 18 months. Participants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Isolated Abdominal Wall Transplant

Arm Type

Experimental

Arm Title

Abdominal Wall with Solid Organ Transplant

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Abdominal Wall Transplant with another solid organ transplant

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Abdominal Wall Transplant alone

Intervention Description

Abdominal Wall Transplant alone

Primary Outcome Measure Information:

Title

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

Time Frame

up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Linda Cendales, MD

Phone

919-681-7514

linda.cendales@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kadiyala Ravindra, MD

Phone

919-613-9687

kadiyala.ravindra@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Cendales, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kadiyala Ravindra, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

At this time all data will be de-identified and there is no plan to make individual participant data available to other researchers.

Learn more about this trial

Abdominal Wall Transplant

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