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Hernia graft study halted early – what we know

NCT ID NCT04294446

Disease control Sponsor: Cook Biotech Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the Biodesign Hernia Graft, a device made from pig intestinal tissue, used to strengthen the abdominal wall during ventral hernia repair. It enrolled 74 adults needing surgery for a primary or recurrent hernia. The goal was to track hernia recurrence and side effects like infection over two years. However, the study was terminated early, so the full picture is limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Biodesign Hernia Graft (a device made from pig intestinal tissue to reinforce hernia repair)
What this could lead to
If successful, this could confirm the graft is safe and effective for routine use in ventral hernia repair.
What could go wrong
The study was terminated early, so results may be incomplete. Hernia recurrence and complications like infection remain possible.

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

74 people

The number who actually took part.

Started

Nov 2020

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1\. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft Exclusion Criteria: 1. Known sensitivity to porcine material For the study, the following patients will also be excluded: 2. Age \< 18 years 3. Unable or unwilling to provide informed consent 4. Life expectancy of less than one year from the date of the index procedure 5. Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.

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Conditions

The condition(s) this trial relates to.

Hernia, Ventral

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ventral hernia

Contacts and locations

Locations

  • Queen Elizabeth II Hospital

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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