Phase
Condition
Hernia
Treatment
LiquiBand FIX8 Open Hernia Mesh Fixation Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 LiquiBandFIX8® OHMF device.
Subject is willing and able to comply with the protocol assessments at time ofsurgery and during the post-surgical follow-up period.
Exclusion
Exclusion Criteria:
Subject is undergoing open repair surgery for recurrent hernia, where the primarysurgery was also open. Subjects with recurrent hernia whose primary surgery waslaparoscopic are not excluded.
Subject has an anatomical defect or had prior surgical procedures that in theopinion of the investigator makes them unsuitable for open hernia repair with theLiquiBand 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, inthe opinion of the Investigator, would interfere with his/her ability to participatein the study.
Subject has a known sensitivity to cyanoacrylate or formaldehyde, D&C Violet No.2dye 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.
Study Design
Connect with a study center
Tameside General Hospital
Ashton-under-Lyne,
United KingdomActive - Recruiting
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA
United KingdomActive - Recruiting
Wirral University Teaching Hospital NHS Foundation Trust
Wirral, CH49 5PE
United KingdomActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.