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Glue instead of stitches? new device tested for hernia repair

NCT ID NCT04059640

Disease control Sponsor: Advanced Medical Solutions Ltd. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a glue device called LiquiBand FIX8 to hold hernia mesh in place during open surgery. About 109 people with a first-time inguinal hernia will get the glue, and doctors will check if it works well and causes few side effects over 12 months. The goal is to see if this glue can replace traditional stitches or tacks.

What this could mean

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

Active substance
LiquiBand FIX8 Open Hernia Mesh Fixation Device (a medical glue used to attach hernia mesh during surgery)
What this could lead to
If successful, this could offer a simpler, effective way to fix hernia mesh without extra stitches or tacks, potentially reducing pain and recovery time.
What could go wrong
This is a small, non-randomized study with no comparison group. The device is permanent, and risks include infection, seroma, or testicular issues. Results may not apply to all hernia types.

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

109 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Jul 2026

An estimate. End dates often move.

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.

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: * Subject is able to understand and give informed consent to take part in the study * Subject has a primary inguinal hernia. * Subject is scheduled to undergo open inguinal hernia repair using the LiquiBand FIX8® OHMF device. * Subject is willing and able to comply with the protocol assessments at time of surgery and during the post-surgical follow-up period. Exclusion Criteria: * Subject is undergoing open repair surgery for recurrent hernia, where the primary surgery was also open. Subjects with recurrent hernia whose primary surgery was laparoscopic are not excluded. * Subject has an anatomical defect or had prior surgical procedures that in the opinion of the investigator makes them unsuitable for open hernia repair with the LiquiBand FIX8® OHMF device. * Subject is known to be non-compliant with medical treatment. * Subject is pregnant or actively breastfeeding. * Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study. * Subject has a known sensitivity to cyanoacrylate or formaldehyde, D\&C Violet No.2 dye or any other component of LiquiBand FIX8® OHMF device. * The hernia mesh to be used in the repair is constructed from Polytetrafluoroethylene (PTFE) or absorbable materials. * The hernia mesh to be used in the repair is a self-gripping mesh (e.g. ProGrip). * Subject has active or potential infection at the surgical site. * Subject has a history of keloid formation. * Subject has a known vitamin C or zinc deficiency. * Subject has a connective tissue disorder.

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal

As listed by the trial registrant

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

Inguinal hernia

Contacts and locations

Locations

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, NR31 6LA, United Kingdom

  • Tameside General Hospital

    Ashton-under-Lyne, United Kingdom

  • Wirral University Teaching Hospital NHS Foundation Trust

    Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

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