PMCF Study of LiquiBand FIX8® OHMF Device

Launched by ADVANCED MEDICAL SOLUTIONS LTD. · Aug 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety and performance of a device called LiquiBand FIX8® that is used to help fix inguinal hernias during surgery. An inguinal hernia occurs when tissue pushes through a weak spot in the abdominal muscles, and this study aims to see how well the device works in repairing this condition. The trial is currently recruiting participants aged 65 to 74 who have a primary inguinal hernia and are scheduled for open surgery using this specific device.

To be eligible for the trial, participants need to be able to understand and agree to take part in the study, and they must be able to attend follow-up appointments after surgery. However, certain individuals may not qualify, such as those with recurrent hernias from previous surgeries, specific medical conditions that could affect their participation, or allergies to certain materials in the device. Participants can expect to undergo standard surgery with the LiquiBand FIX8® and will be monitored for their recovery and any potential side effects. This study is important as it may provide valuable information on how this device can improve surgical outcomes for patients with inguinal hernias.

Gender

ALL

Eligibility criteria

• 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.