Status:
ACTIVE_NOT_RECRUITING
PMCF Study of LiquiBand FIX8® OHMF Device
Lead Sponsor:
Advanced Medical Solutions Ltd.
Collaborating Sponsors:
Imarc Research, Inc.
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04059640
Start Date
December 7 2021
End Date
July 31 2026
Last Update
October 2 2025
Active Locations (3)
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1
Tameside General Hospital
Ashton-under-Lyne, United Kingdom
2
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom, NR31 6LA
3
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom, CH49 5PE