PMCF Study of LiquiBand FIX8® OHMF Device

NCT04059640 | Active Not Recruiting

• 1 other identifier: OHMF-001
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Inguinal Hernia

Keywords

Inguinal Hernia; Mesh Fixation; Surgical Site Wound Closure

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the LiquiBand FIX8 OHMF device

  Effectiveness will be defined as successful fixation of the hernia mesh (ie not requiring additional fixation by an alternate device) using the LiquiBand FIX8 device at the time of surgery. Based on data pooled from published studies of a similar device (which employs the same cyanoacrylate glue to fix hernia mesh, via a laparoscopic rather than open surgical approach), there has been an observed failure rate of 0.8% in mesh fixation. This study aims to demonstrate non-inferiority of the LiquiBand FIX8 device to a failure rate of 5% (medically acceptable inference).

  Time of surgery

Secondary Outcomes (7)

• Safety of the LiquiBand FIX8 OHMF device

  0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery

• Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure

  Time of surgery

• Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state.

  12-months post-surgery

• Long term performance of the study device

  12-months post surgery

• Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.

  12-months

Other Outcomes (1)

• Cosmesis of wound closure using the Visual Analogue Scale

  12-months

Study Arms (1)

LiquiBand FIX8® OHMF Device

EXPERIMENTAL

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

Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device

Interventions

LiquiBand FIX8 Open Hernia Mesh Fixation Device 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.

LiquiBand FIX8® OHMF Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead
• Imarc Research, Inc.: collaborator

Study Sites (3)

Tameside General Hospital

Ashton-under-Lyne, United Kingdom

Location

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, NR31 6LA, United Kingdom

Location

Wirral University Teaching Hospital NHS Foundation Trust

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrei Mihailescu, MD

  Tameside & Glossop Integrated Care NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 16, 2019
• Study Start: December 7, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)