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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059640
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 6, 2023
Sponsor:
Collaborator:
Imarc Research, Inc.
Information provided by (Responsible Party):
Advanced Medical Solutions Ltd.

Tracking Information
First Submitted Date  ICMJE August 9, 2019
First Posted Date  ICMJE August 16, 2019
Last Update Posted Date September 6, 2023
Actual Study Start Date  ICMJE December 7, 2021
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2019)		 Effectiveness of the LiquiBand FIX8 OHMF device [ Time Frame: Time of surgery ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2021)
  • Safety of the LiquiBand FIX8 OHMF device [ Time Frame: 0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery ]
    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 [ Time Frame: Time of surgery ]
    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. [ Time Frame: 12-months post-surgery ]
    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 [ Time Frame: 12-months post surgery ]
    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. [ Time Frame: 12-months ]
    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. [ Time Frame: 12-months ]
    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 [ Time Frame: 0 (Post Surgery) and upto 2 days (hospital discharge) ]
    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))
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • Safety of the LiquiBand FIX8 OHMF device [ Time Frame: 0 (intra-operatively), up to 2 days (discharge from hospital), 4-weeks, 3-months, 6-months and 12-months post surgery ]
    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 ≥ 6 months post-surgery
  • Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure [ Time Frame: Time of surgery ]
    Defined as successful closure of the incision site using the LiquiBand FIX8 Device (not requiring additional fixation by an alternate device).
  • Assessment of acute post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state. [ Time Frame: 4-weeks post-surgery ]
    Acute post-operative pain will be assessed using the following measures:
    • Improvement in post-operative pain from baseline to 4 weeks post-surgery as measured by the Visual Analogue Scale (0 = no pain to 10 = most pain imaginable); and
    • Analgesic requirements in the first 4 weeks post-surgery
  • Long term performance of the study device [ Time Frame: 4-weeks, 6-months and 12-months ]
    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. [ Time Frame: 12-months ]
    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. [ Time Frame: 12-months ]
    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 [ Time Frame: 0 (Post Surgery) and upto 2 days (hospital discharge) ]
    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))
Current Other Pre-specified Outcome Measures
 (submitted: April 14, 2020)		 Cosmesis of wound closure using the Visual Analogue Scale [ Time Frame: 12-months ]
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).
Original Other Pre-specified Outcome Measures
 (submitted: August 15, 2019)		 Cosmesis of wound closure using the Visual Analogue Scale [ Time Frame: 3-months, 6-months and 12-months ]
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).
 
Descriptive Information
Brief Title  ICMJE PMCF Study of LiquiBand FIX8® OHMF Device
Official Title  ICMJE PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
Brief Summary Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inguinal Hernia
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: LiquiBand FIX8® OHMF Device
Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.
Intervention: Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2019)		 107
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tina Warburton 01606863500 tina.warburton@admedsol.com
Contact: Rebecca Forder 01606863500 rebecca.forder@admedsol.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04059640
Other Study ID Numbers  ICMJE OHMF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Advanced Medical Solutions Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Advanced Medical Solutions Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Imarc Research, Inc.
Investigators  ICMJE
Principal Investigator: Andrei Mihailescu, MD Tameside & Glossop Integrated Care NHS Foundation Trust
PRS Account Advanced Medical Solutions Ltd.
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP