PMCF Study of LiquiBand FIX8® OHMF Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2026-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LiquiBand FIX8® OHMF Device

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

Group Type EXPERIMENTAL

LiquiBand FIX8 Open Hernia Mesh Fixation Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No