search
Back to results

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

Primary Purpose

Inguinal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
LiquiBand FIX8 Open Hernia Mesh Fixation Device
Sponsored by
Advanced Medical Solutions Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal Hernia, Mesh Fixation, Surgical Site Wound Closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tameside General HospitalRecruiting
  • James Paget University Hospitals NHS Foundation TrustRecruiting
  • Wirral University Teaching Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LiquiBand FIX8® OHMF Device

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Safety of the LiquiBand FIX8 OHMF device
The incidence of adverse events (whether or not determined to be related to the LiquiBand FIX8 Device) will be recorded. Complications assessed during the study will include: Haematoma Seroma Testicular ischaemia and atrophy Surgical site or wound infection/dehiscence Mesh infection Chronic post-operative pain (lasting ≥ 12 months post-surgery
Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure
Defined as successful closure of the incision site using the LiquiBand FIX8 Device (not requiring additional fixation by an alternate device).
Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state.
Chronic post-operative pain will be assessed using the following measures: Improvement in post-operative pain from baseline to 12 months post-surgery as measured by the Visual Analogue Scale (0 = no pain to 10 = most pain imaginable); and Analgesic requirements in the 12 months post-surgery
Long term performance of the study device
Long-term performance will be assessed by rate of hernia recurrence.
Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.
A study-specific outcome model will be used, which will calculate an incremental cost effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation).
Comparison of costs of patients' clinical events treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.
A study-specific outcome model will be used which will calculate an incremental cost effectiveness ratio (ICER) given in terms of clinical events avoided achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation).
Clinician satisfaction
Users will be asked to rate the device on factors relating to ease of use and satisfaction, compared with their experience of other hernia mesh fixation devices. Satisfaction will be assessed using a Likert-type scale (e.g. Very satisfied (1), Satisfied (2), Neither (3), Dissatisfied (4), Very dissatisfied (5))

Full Information

First Posted
August 9, 2019
Last Updated
September 4, 2023
Sponsor
Advanced Medical Solutions Ltd.
Collaborators
Imarc Research, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04059640
Brief Title
PMCF Study of LiquiBand FIX8® OHMF Device
Acronym
LBF8-Open
Official Title
PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Solutions Ltd.
Collaborators
Imarc Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal Hernia, Mesh Fixation, Surgical Site Wound Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LiquiBand FIX8® OHMF Device
Arm Type
Experimental
Arm Description
Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.
Intervention Type
Device
Intervention Name(s)
LiquiBand FIX8 Open Hernia Mesh Fixation Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the LiquiBand FIX8 OHMF device
Description
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 Frame
Time of surgery
Secondary Outcome Measure Information:
Title
Safety of the LiquiBand FIX8 OHMF device
Description
The incidence of adverse events (whether or not determined to be related to the LiquiBand FIX8 Device) will be recorded. Complications assessed during the study will include: Haematoma Seroma Testicular ischaemia and atrophy Surgical site or wound infection/dehiscence Mesh infection Chronic post-operative pain (lasting ≥ 12 months post-surgery
Time Frame
0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery
Title
Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure
Description
Defined as successful closure of the incision site using the LiquiBand FIX8 Device (not requiring additional fixation by an alternate device).
Time Frame
Time of surgery
Title
Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state.
Description
Chronic post-operative pain will be assessed using the following measures: Improvement in post-operative pain from baseline to 12 months post-surgery as measured by the Visual Analogue Scale (0 = no pain to 10 = most pain imaginable); and Analgesic requirements in the 12 months post-surgery
Time Frame
12-months post-surgery
Title
Long term performance of the study device
Description
Long-term performance will be assessed by rate of hernia recurrence.
Time Frame
12-months post surgery
Title
Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.
Description
A study-specific outcome model will be used, which will calculate an incremental cost effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation).
Time Frame
12-months
Title
Comparison of costs of patients' clinical events treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.
Description
A study-specific outcome model will be used which will calculate an incremental cost effectiveness ratio (ICER) given in terms of clinical events avoided achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation).
Time Frame
12-months
Title
Clinician satisfaction
Description
Users will be asked to rate the device on factors relating to ease of use and satisfaction, compared with their experience of other hernia mesh fixation devices. Satisfaction will be assessed using a Likert-type scale (e.g. Very satisfied (1), Satisfied (2), Neither (3), Dissatisfied (4), Very dissatisfied (5))
Time Frame
0 (Post Surgery) and upto 2 days (hospital discharge)
Other Pre-specified Outcome Measures:
Title
Cosmesis of wound closure using the Visual Analogue Scale
Description
Cosmesis of the wound closure will be assessed by the investigator and patient, and measured by Visual Analogue Scale (0 = Very poor cosmetic outcome; to 10 = very good cosmetic outcome).
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Warburton
Phone
01606863500
Email
tina.warburton@admedsol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Forder
Phone
01606863500
Email
rebecca.forder@admedsol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Mihailescu, MD
Organizational Affiliation
Tameside & Glossop Integrated Care NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tameside General Hospital
City
Ashton-under-Lyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrei Mihailescu
Facility Name
James Paget University Hospitals NHS Foundation Trust
City
Great Yarmouth
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Liao
Facility Name
Wirral University Teaching Hospital NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conor Magee

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PMCF Study of LiquiBand FIX8® OHMF Device

We'll reach out to this number within 24 hrs