PMCF Study of LiquiBand FIX8® OHMF Device
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
View NCT04059640 on ClinicalTrials.gov ↗ ← All trials in the UK