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New mesh shows promise for fixing stomach hernias

NCT ID NCT04282720

Disease control Sponsor: Kettering Health Network 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tested a biological mesh called SurgiMend during laparoscopic hiatal hernia repair in 9 adults. The goal was to see if the mesh helps prevent the hernia from coming back and improves quality of life. Participants were followed for 6 months with X-rays and surveys.

What this could mean

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

Active substance
SurgiMend biological mesh
What this could lead to
If successful, this mesh could reduce hernia recurrence and improve quality of life after hiatal hernia repair.
What could go wrong
This is a very small pilot study with only 9 participants and no comparison group, so results may not apply to everyone. The mesh is made from animal tissue, which could cause allergic reactions.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of type 3 or 4 hiatal hernia (8) * Subject is able to give informed consent * Adults at least 18 years of age Exclusion Criteria: * Currently pregnant * Prior hiatal hernia repair * Prior gastric surgery * Prior foregut surgery * Known esophageal dysfunction or dysmotility * Cirrhosis or ascites * Known malignancy * Known allergy to biologic mesh * Known allergy to barium or other contrast material used in UGI * Religious objection to animal implant * Cognitive impairment * Prisoners

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Conditions

The condition(s) this trial relates to.

hiatus hernia

As listed by the trial registrant

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

Hiatal hernia

Contacts and locations

Locations

  • Kettering Health Network - Grandview Medical Center

    Dayton, Ohio, 45405, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.