Donor belly tissue may fix tough hernias when mesh fails
NCT ID NCT07326826
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to repair complex abdominal wall hernias using donated belly wall tissue (fascia) instead of synthetic mesh. It includes 20 people who are either organ transplant recipients or have no good standard options. The goal is to see if the graft is safe and works over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor abdominal wall tissue graft (allogeneic non-vascularized rectus abdominis fascial graft)
- What this could lead to
- If successful, this could offer a new surgical option for repairing difficult hernias when standard methods fail or synthetic mesh is unsafe.
- What could go wrong
- This is a very small pilot study with only 20 people, so results may not apply widely. The graft could fail, cause infection, or trigger an immune response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients (≥18 years) undergoing elective incisional or primary ventral hernia repair with implantation of an allogeneic non-vascularized rectus abdominis fascial graft (NVRF). Eligible participants include solid organ transplant recipients at least 6 months post-transplant (liver, kidney, pancreas, heart, or combined transplants) and highly selected non-transplant patients with complex abdominal wall fascial defects not amenable to standard reconstruction (e.g., mesh repair, flap transposition, component separation) or with contraindications to synthetic mesh. Participants must provide written informed consent and have ECOG performance status 0-2. Pregnant patients, patietns with performance status ECOG 3-4, and on high-dose corticosteroid therapy are excluded.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years. * Solid organ transplant recipients (liver, kidney, pancreas, heart, or combined transplantation) ≥ 6 months post-transplantation with a primary ventral or incisional hernia. * Non-transplant patients with a complex abdominal wall defect not amenable to currently established reconstructive methods (e.g., mesh repair, flap transposition, component separation). * ECOG performance status 0-2. * Written informed consent. Exclusion Criteria: * ECOG performance status 3-4. * Pregnancy. * High-dose corticosteroid therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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