LiquiBand FIX8 Open Hernia Mesh Fixation Device: Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.
Subjects will be evaluated intra-operatively, post-operatively, at discharge, and at 12 months post-operatively. The Liquiband surgical study device is considered a permanent implant.
Study summary
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Effectiveness of the LiquiBand FIX8 OHMF device — Time of surgery Effectiveness will be defined as successful fixation of the hernia mesh (ie not requiring additional fixation by an alternate device) using the LiquiBand FIX8 device at the time of surgery. Based on data pooled from published studies of a similar device (which employs the same cyanoacrylate glue to fix hernia mesh, via a laparoscopic rather than open surgical approach), there has been an observed failure rate of 0.8% in mesh fixation. This study aims to demonstrate non-inferiority of the LiquiBand FIX8 device to a failure rate of 5% (medically acceptable inference).
Trial sites (3)
Facility
City
Region
Status
Tameside General Hospital
Ashton-under-Lyne
United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth
United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral
United Kingdom
More Advanced Medical Solutions Ltd. trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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