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Clinical Trials in the UK / NCT04059640
Active, not recruiting Not applicable

PMCF Study of LiquiBand FIX8® OHMF Device

NCT04059640 · tracked via the Priya Life Science UK tracker
Sponsor
Advanced Medical Solutions Ltd.
Phase
Not applicable
Started
2021-12-07
Last updated
2025-10-02

Condition(s) studied

Inguinal Hernia

Investigational drug(s) / intervention(s)

LiquiBand FIX8 Open Hernia Mesh Fixation Device

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)

Trial sites (3)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT04059640 on ClinicalTrials.gov ↗ ← All trials in the UK