PMCF Study of LiquiBand FIX8® OHMF Device

Last updated: January 27, 2025
Sponsor: Advanced Medical Solutions Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

LiquiBand FIX8 Open Hernia Mesh Fixation Device

Clinical Study ID

NCT04059640
OHMF-001
  • Ages > 18
  • All Genders

Study Summary

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

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

Total Participants: 107
Treatment Group(s): 1
Primary Treatment: LiquiBand FIX8 Open Hernia Mesh Fixation Device
Phase:
Study Start date:
December 07, 2021
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Tameside General Hospital

    Ashton-under-Lyne,
    United Kingdom

    Active - Recruiting

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, NR31 6LA
    United Kingdom

    Active - Recruiting

  • Wirral University Teaching Hospital NHS Foundation Trust

    Wirral, CH49 5PE
    United Kingdom

    Active - 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.