ClinicalTrials.gg
RecruitingNCT03310905Updated Jan 7, 2026

Abdominal Wall Transplant

An interventional study of Abdominal Wall Transplant with another solid organ transplant and Abdominal Wall Transplant alone in Transplant;Failure,Kidney, Transplant; Failure, Liver and Transplant; Failure, Bowel, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2018; still recruiting 8 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's planned enrollment of 5 is below the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • at evaluation or history of malignancy that precludes transplantation
  • Pregnancy: Women who are of must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Isolated Abdominal Wall Transplant

    Procedure: Abdominal Wall Transplant alone

  • Experimental
    Abdominal Wall with Solid Organ Transplant

    Procedure: Abdominal Wall Transplant with another solid organ transplant

Interventions

  • ProcedureAbdominal Wall Transplant with another solid organ transplant

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

  • ProcedureAbdominal Wall Transplant alone

    Abdominal Wall Transplant alone

06

What researchers measure

Primary outcomes

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

    Time frame: up to 18 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310905
Lead sponsor
Duke University
Collaborators
Linda Cendales, MD, Kadiyala Ravindra, M.D., Detlev Erdmann, M.D.
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
May 1, 2018
Primary completion
Jan 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Jan 7, 2026

Study contacts

Linda Cendales, MD
Contact
linda.cendales@duke.edu
919-681-7514
Kadiyala Ravindra, MD
Contact
kadiyala.ravindra@duke.edu
919-613-9687
Linda Cendales, MD
principal investigator · Duke University
Kadiyala Ravindra, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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