Hernia Incisional VentralLBF8-03NCT07295379
LIQUIBAND FIX8® for Ventral Incisional Hernia
An observational study of Hernia Incisional Ventral, run by Advanced Medical Solutions Ltd. at 1 site in United Kingdom.
Trial summary
This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia Incisional Ventral
- What is being tested?
- LIQUIBAND FIX8
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2026to 30 Jul 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers for ventral incisional hernia repair at Royal Lancaster Infirmary performed by study Investigator
Who may be able to join
- Patient is ≥ 18 years of age and ≤ 80 years of age.
- Patient had a ventral incisional hernia (this may include both primary and recurrent).
- Patient underwent a ventral incisional repair and LIQUIBAND FIX8® adhesive was used for mesh fixation (including those patients where supplemental fixation was used)
- Has a minimum of 12 months follow-up.
Who cannot join
- Concomitant parastomal hernia repair
- No other exclusions specific to the device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Single Centre, Observational Study to Evaluate the Safety and Effectiveness of LIQUIBAND FIX8® When Used for Mesh Fixation During Ventral Incisional Hernia Repair.
This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked). This is a retrospective post market clinical follow-up study to collect information about the use of the device in a real-world setting for ventral incisional hernia repair. Ventral incisional hernias occur following surgery and the most common method of treatment includes implanting a mesh, which in the case of ventral incisional hernia, the standard of care is intra-peritoneal onlay mesh. This is fixed in place using sutures, tacks or adhesive.
The LiquiBand FIX8 Open device is an atraumatic device specifically engineered for strong mesh fixation of hernia repair meshes. Hernia repair meshes are woven sheets of flexible synthetic plastic which are placed tension-free over the weakness in the peritoneum abdominal wall, essentially 'plugging' it up. Tension is created in the abdominal wall during repair, but the mesh allows this tension to be spread out. The mesh must be secured to the underlying tissue and this is often done with the use of tacks or sutures, however, the study device instead uses a glue (N-Butyl 2 cyanoacrylate adhesive) to secure the mesh. The FIX8 Open device is designed for the application of this glue to the implanted hernia repair mesh in order to fix the mesh to the underlying tissue. When the glue is applied to the mesh and tissue, it polymerises (forms a chemical bond) due to the moisture on the tissue surface within approximately 10 seconds and allows the mesh to remain in the correct position. The study device can also be used to close topical wounds (the opening that the surgeon makes on the surface to access the hernia).
- Conditions
- Hernia Incisional Ventral
- Being tested
- LIQUIBAND FIX8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIQUIBAND FIX8Device
Study device
| Study group | Role | What they receive |
|---|---|---|
| All comers | All comers treated with the study device Receives: Device: LIQUIBAND FIX8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of LIQUIBAND FIX8
The performance of LIQUIBAND FIX8® adhesive when used as a method of mesh fixation (independently or in conjunction with another mesh fixation device) during ventral incisional hernia, through reported hernia recurrence rates at 12 months post-surgery.
Measured: From surgery to end of follow-up at 12 months
Secondary outcomes (4)
Reoperation incidence
To evaluate the incidence of reoperation following ventral incisional hernia repair using LIQUIBAND FIX8 as the method of mesh fixation (independently or in conjunction with another mesh fixation device) at discharge, 6-12 weeks follow up and 12 months post-surgery.
Measured: From surgery to end of follow-up at 12-months
SSI incidence
To evaluate the incidence of surgical site infection following ventral incisional hernia repair using LIQUIBAND FIX8 as the method of mesh fixation (independently or in conjunction with another mesh fixation device) at discharge, 6-12 weeks follow up and 12 months post-surgery.
Measured: From surgery to end of follow-up at 12-months
Chronic pain incidence
To evaluate the incidence of chronic pain following ventral incisional hernia repair i.e. beyond 3 months surgery
Measured: From surgery to end of follow-up at 12-months
Adverse Events
To assess post market safety through the reporting of adverse events following ventral incisional hernia repair using LIQUIBAND FIX8 as the method of mesh fixation (independently or in conjunction with another mesh fixation device) at discharge, 6-12 weeks follow up and 12 months post-surgery.
Measured: From surgery to end of follow-up at 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start2 Feb 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia Incisional VentralStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295379
- Sponsor's protocol ID
- LBF8-03
- Acronym
- LBF8-03
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 8 Jul 2026
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single Centre, Observational Study to Evaluate the Safety and Effectiveness of LIQUIBAND FIX8® When Used for Mesh Fixation During Ventral Incisional Hernia Repair.
- ClinicalTrials.gov ID
- NCT07295379
- Acronym / sponsor ID
- LBF8-03 / LBF8-03
- Conditions
- Hernia Incisional Ventral
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 19 Dec 2025 (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.
This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked). This is a retrospective post market clinical follow-up study to collect information about the use of the device in a real-world setting for ventral incisional hernia repair. Ventral incisional hernias occur following surgery and the most common method of treatment includes implanting a mesh, which in the case of ventral incisional hernia, the standard of care is intra-peritoneal onlay mesh. This is fixed in place using sutures, tacks or adhesive.
The LiquiBand FIX8 Open device is an atraumatic device specifically engineered for strong mesh fixation of hernia repair meshes. Hernia repair meshes are woven sheets of flexible synthetic plastic which are placed tension-free over the weakness in the peritoneum abdominal wall, essentially 'plugging' it up. Tension is created in the abdominal wall during repair, but the mesh allows this tension to be spread out. The mesh must be secured to the underlying tissue and this is often done with the use of tacks or sutures, however, the study device instead uses a glue (N-Butyl 2 cyanoacrylate adhesive) to secure the mesh. The FIX8 Open device is designed for the application of this glue to the implanted hernia repair mesh in order to fix the mesh to the underlying tissue. When the glue is applied to the mesh and tissue, it polymerises (forms a chemical bond) due to the moisture on the tissue surface within approximately 10 seconds and allows the mesh to remain in the correct position. The study device can also be used to close topical wounds (the opening that the surgeon makes on the surface to access the hernia).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All comers | – | Device: LIQUIBAND FIX8All comers treated with the study device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers for ventral incisional hernia repair at Royal Lancaster Infirmary performed by study Investigator
Key inclusion criteria (4 listed)
- Patient is ≥ 18 years of age and ≤ 80 years of age.
- Patient had a ventral incisional hernia (this may include both primary and recurrent).
- Patient underwent a ventral incisional repair and LIQUIBAND FIX8® adhesive was used for mesh fixation (including those patients where supplemental fixation was used)
- Has a minimum of 12 months follow-up.
Key exclusion criteria (2 listed)
- Concomitant parastomal hernia repair
- No other exclusions specific to the device
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 FIX8Study device | Device | All comers |
Primary outcome
Performance of LIQUIBAND FIX8
Time frame: From surgery to end of follow-up at 12 months
The performance of LIQUIBAND FIX8® adhesive when used as a method of mesh fixation (independently or in conjunction with another mesh fixation device) during ventral incisional hernia, through reported hernia recurrence rates at 12 months post-surgery.
4 secondary outcomes
Reoperation incidence
Time frame: From surgery to end of follow-up at 12-months
SSI incidence
Time frame: From surgery to end of follow-up at 12-months
Chronic pain incidence
Time frame: From surgery to end of follow-up at 12-months
Adverse Events
Time frame: From surgery to end of follow-up at 12-months
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 8 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia Incisional Ventral, run by Advanced Medical Solutions Ltd. at 1 site 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 2 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Performance of LIQUIBAND FIX8 (time frame: From surgery to end of follow-up at 12 months). 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 8 Jul 2026.