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Procedure

Abdominal Wall Transplant for Abdominal Wall Defects

N/A
Recruiting
Led By Kadiyala Ravindra, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidates between 18-65 years old
Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke
Must not have
Medical exclusion criteria for general anesthesia
Malignancy at evaluation or history of malignancy that precludes transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will test whether abdominal wall transplantation is a safe and effective treatment for abdominal wall defects.

Who is the study for?
This trial is for adults aged 18-65 with severe abdominal wall defects, possibly needing an additional organ transplant. Candidates must be able to consent and meet criteria for a non-vascularized composite allograft at Duke. Exclusions include cancer history, pregnancy or potential pregnancy without agreed contraception use, anesthesia risks, and untreated substance abuse.
What is being tested?
The study is testing the safety and effectiveness of abdominal wall transplants either as a standalone procedure or alongside another solid organ transplant. The goal is to see how well this surgery repairs serious abdominal wall problems.
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection, rejection of the transplanted tissue, complications from general anesthesia, pain at the surgery site, and issues related to long-term immunosuppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am eligible for an organ transplant at Duke, including my abdominal wall.
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I am willing and legally able to consent to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am medically cleared for general anesthesia.
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My cancer or past cancer prevents me from having a transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Isolated Abdominal Wall TransplantExperimental Treatment1 Intervention
Group II: Abdominal Wall with Solid Organ TransplantExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,066,079 Total Patients Enrolled
Linda Cendales, MDUNKNOWN
Detlev Erdmann, M.D.UNKNOWN

Media Library

Abdominal Wall Transplant (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03310905 — N/A
Abdominal Wall Fistula Research Study Groups: Isolated Abdominal Wall Transplant, Abdominal Wall with Solid Organ Transplant
Abdominal Wall Fistula Clinical Trial 2023: Abdominal Wall Transplant Highlights & Side Effects. Trial Name: NCT03310905 — N/A
Abdominal Wall Transplant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03310905 — N/A
~2 spots leftby Jan 2028
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