Inguinal HerniaLBF8-OpenNCT04059640
PMCF Study of LiquiBand FIX8® OHMF Device
A study testing LiquiBand FIX8 Open Hernia Mesh Fixation Device in people with Inguinal Hernia, run by Advanced Medical Solutions Ltd. at 3 sites in United Kingdom.
Trial summary
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 7 Dec 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Tameside General Hospital
Ashton-under-Lyne
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, CH49 5PE
About this study
Official title: PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
- Conditions
- Inguinal Hernia
- Being tested
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Keywords
- Inguinal Hernia, Mesh Fixation, Surgical Site Wound Closure
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiBand FIX8 Open Hernia Mesh Fixation DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| LiquiBand FIX8® OHMF Device | Experimental | Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device. Receives: Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Time of surgery
Secondary outcomes (7)
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
Measured: 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
Defined as successful closure of the incision site using the LiquiBand FIX8 Device (not requiring additional fixation by an alternate device).
Measured: Time of surgery
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
Measured: 12-months post-surgery
Long term performance of the study device
Long-term performance will be assessed by rate of hernia recurrence.
Measured: 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.
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).
Measured: 12-months
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).
Measured: 12-months
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))
Measured: 0 (Post Surgery) and upto 2 days (hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start7 Dec 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imarc Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrei Mihailescu, MD, Principal investigator, Tameside & Glossop Integrated Care NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059640
- Sponsor's protocol ID
- OHMF-001
- Acronym
- LBF8-Open
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
- ClinicalTrials.gov ID
- NCT04059640
- Acronym / sponsor ID
- LBF8-Open / OHMF-001
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal Hernia, Mesh Fixation, Surgical Site Wound Closure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Imarc Research, Inc.
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LiquiBand FIX8® OHMF Device | Experimental | Device: LiquiBand FIX8 Open Hernia Mesh Fixation DeviceSubjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiquiBand FIX8 Open Hernia Mesh Fixation DeviceSubjects 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. | Device | LiquiBand FIX8® OHMF Device |
Primary outcome
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).
7 secondary outcomes
Safety of the LiquiBand FIX8 OHMF device
Time frame: 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 frame: Time of surgery
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
Long term performance of the study device
Time frame: 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.
Time frame: 12-months
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
Clinician satisfaction
Time frame: 0 (Post Surgery) and upto 2 days (hospital discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Mihailescu, MD principal investigator
Tameside & Glossop Integrated Care NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquiBand FIX8 Open Hernia Mesh Fixation Device in people with Inguinal Hernia, run by Advanced Medical Solutions Ltd. at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the LiquiBand FIX8 OHMF device (time frame: Time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025; AzTrials last refreshed its copy on 27 Oct 2026.