Evaluation of a new device for fixing inguinal hernias

PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device

This study is testing a new device to see if it safely helps fix inguinal hernias during surgery for people who need this type of repair.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Advanced Medical Solutions Ltd. (Industry-sponsored)
• Locations: 3 sites (Ashton-under-Lyne and 2 other locations)
• Trial ID: NCT04059640 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and performance of the LiquiBand FIX8 Open Hernia Mesh Fixation Device in patients undergoing open inguinal hernia repair. Participants will be monitored during surgery and through post-surgical follow-ups to evaluate outcomes related to the device's effectiveness. The study includes individuals with primary inguinal hernias who are scheduled for surgery using this specific device. The goal is to gather data that could support the device's use in clinical practice.

Who should consider this trial

Good fit: Ideal candidates are adults with a primary inguinal hernia scheduled for open repair surgery using the LiquiBand FIX8 device.

Not a fit: Patients with recurrent hernias or those with significant medical conditions that prevent safe surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing inguinal hernia repair.

How similar studies have performed: While this approach is being evaluated for the first time with this specific device, similar studies on mesh fixation devices have shown promising results in the past.

Eligibility criteria

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.

Where this trial is running

Ashton-under-Lyne and 2 other locations

• Tameside General Hospital — Ashton-under-Lyne, United Kingdom (Recruiting)
• James Paget University Hospitals NHS Foundation Trust — Great Yarmouth, United Kingdom (Recruiting)
• Wirral University Teaching Hospital NHS Foundation Trust — Wirral, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Andrei Mihailescu, MD — Tameside & Glossop Integrated Care NHS Foundation Trust
• Study coordinator: Tina Warburton

Conditions Inguinal Hernia; Mesh Fixation; Surgical Site Wound Closure