PMCF Study of LiquiBand FIX8® OHMF Device (LBF8-Open)

Advanced Medical Solutions

Status: Active, not recruiting

Conditions: Inguinal Hernia

Treatments: Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04059640

OHMF-001

Details and patient eligibility

About

Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

LiquiBand FIX8® OHMF Device

Experimental group

Description:

Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.

Treatment:

Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device