HerniaNCT04009213
A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
A study testing LiquiBand FIX8® and AbsorbaTack™ in people with Hernia and Inguinal Hernia, run by Advanced Medical Solutions Ltd. at 6 sites in United States.
Trial summary
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hernia, Inguinal Hernia, Femoral Hernia
- What is being tested?
- LiquiBand FIX8® and AbsorbaTack™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Aug 2019to 23 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female, ≥22 years of age
- Is willing and able to give written informed consent
- Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral)
- Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or femoral)
- Hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the following;
- 3D Max™ Mesh (Bard Inc.)
Show all 10Show fewer
- 3D Max™ Light (Bard Inc.)
- Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic)
- Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic)
- 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
- Has a hernia type not suitable for laparoscopic hernia repair as determined by the Investigator (i.e. strangulated)
- Subject has a recurrent groin hernia previously repaired laparoscopically, has an anatomical defect or had prior surgical procedures that in the opinion of the Investigator prevents access to the pre-peritoneal space for TAPP or TEP laparoscopic hernia repair
- Is pregnant or actively breastfeeding
- Has a known sensitivity to cyanoacrylate or formaldehyde,D\&C Violet No.2 dye or any component of LiquiBand FIX8® or control device
- Has an active or potential infection at the surgical site or systemic sepsis
- Hernia mesh to be used at surgery is less than 4"x6" in size, or not one of the types of mesh listed in Inclusion Criteria above
- Cannot tolerate general anaesthesia
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Overlake Medical Center
Bellevue, Washington, 98004
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
Greenville Memorial Hospital
Greenville, South Carolina, 29605
University of Kentucky College of Medicine UK Medical Center
Lexington, Kentucky, 40506
Cleveland Clinic
Weston, Florida, 33331
About this study
Official title: A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale).
- Conditions
- Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia
- Being tested
- LiquiBand FIX8®, AbsorbaTack™
- Keywords
- Laparoacopic, Peritoneal Closure
- Medical subject headings
- Hernia, Hernia, Inguinal, Hernia, Femoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiBand FIX8®Device
An n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye
AbsorbaTack™Device
An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2.
| Study group | Role | What they receive |
|---|---|---|
| LiquiBand FIX8® | Experimental | LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye Receives: Device: LiquiBand FIX8® |
| AbsorbaTack™ | Active comparator | AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2 Receives: Device: AbsorbaTack™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
Measured: Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.
Secondary outcomes (6)
Number of Participants With Hernia Recurrence
The incidence of hernia recurrence was assessed by physical examination and confirmed by ultrasound imaging following physical examination. Also, the study sites were guided to ask the subjects 3 questions during the clinic visit performed remotely with a 'Yes' or 'No' response; 1. Do you think your hernia has come back? 2. Do you feel or see a bulge? and 3. Do you have physical pain or symptoms at the site?
Measured: Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported
Successful Mesh Fixation at the Time of Surgery.
LiquiBand FIX8® was required to successfully fix hernia mesh at a rate non-inferior to control device (AbsorbaTack™). Successful mesh fixation did not require any additional fixation by alternate fixation device.
Measured: Time of surgery.
Incidence of Successful Peritoneal Closure (TAPP Repairs Only)
LiquiBand FIX8® was required to successfully approximate the peritoneum at a rate non-inferior to control device. Successful peritoneal closure did not require any additional fixation by alternate fixation device or additional procedure.
Measured: Time of surgery.
Quality of Life as Measured by the Carolinas Comfort Scale (CCS).
Quality of Life was assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire. CCS scores at each timepoint were compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. Carolinas Comfort Scale measures quality of life through a 23-item, Likert-type questionnaire that measures severity of pain, sensation of mesh and movement limitations in eight categories: laying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs and exercise. The subscales scores for pain (0-40), sensation of mesh (0-40) and movement limitations (0-35) are combined to provide a total CCS score. The best possible score is 0 and the worst possible score is 115.
Measured: Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).
A Visual Analog Scale (VAS) was used as a measure of pain where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
Measured: Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Safety as Measured by the Incidence of Adverse Events.
The number of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™).
Measured: Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start22 Aug 2019
- Primary completion13 Jun 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to one of two treatment arms, LiquiBand FIX8® or Control (AbsorbaTack™) device at a 1:1 ratio. Subjects will also be randomized according to laparoscopic technique used (TEP or TAPP hernia repair procedure), so that there is appropriate distribution between the Investigational and control devices. Randomization will occur immediately prior to use of either device for mesh fixation (TEP repairs) or mesh fixation and peritoneal closure (TAPP repairs only) and only after the Investigator has laparoscopically inspected the site of repair and determined the patient to be eligible for participation in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John S Roth, Medicine, Principal investigator, University of Kentucky College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009213
- Sponsor's protocol ID
- LBF8-01 Version 1.3
- Status last verified
- Jan 2024
- First submitted
- 28 Jun 2019
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
- ClinicalTrials.gov ID
- NCT04009213
- Acronym / sponsor ID
- LBF8-01 Version 1.3
- Conditions
- Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia
- Keywords
- Laparoacopic, Peritoneal Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of two treatment arms, LiquiBand FIX8® or Control (AbsorbaTack™) device at a 1:1 ratio. Subjects will also be randomized according to laparoscopic technique used (TEP or TAPP hernia repair procedure), so that there is appropriate distribution between the Investigational and control devices. Randomization will occur immediately prior to use of either device for mesh fixation (TEP repairs) or mesh fixation and peritoneal closure (TAPP repairs only) and only after the Investigator has laparoscopically inspected the site of repair and determined the patient to be eligible for participation in the study.
| Arm | Type | Receives |
|---|---|---|
| LiquiBand FIX8® | Experimental | Device: LiquiBand FIX8®LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye |
| AbsorbaTack™ | Active comparator | Device: AbsorbaTack™AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is male or female, ≥22 years of age
- Is willing and able to give written informed consent
- Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral)
- Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or femoral)
- Hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the following;
Key exclusion criteria (8 listed)
- Has a hernia type not suitable for laparoscopic hernia repair as determined by the Investigator (i.e. strangulated)
- Subject has a recurrent groin hernia previously repaired laparoscopically, has an anatomical defect or had prior surgical procedures that in the opinion of the Investigator prevents access to the pre-peritoneal space for TAPP or TEP laparoscopic hernia repair
- Is pregnant or actively breastfeeding
- Has a known sensitivity to cyanoacrylate or formaldehyde,D\&C Violet No.2 dye or any component of LiquiBand FIX8® or control device
- Has an active or potential infection at the surgical site or systemic sepsis
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®An n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye | Device | LiquiBand FIX8® |
| AbsorbaTack™An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2. | Device | AbsorbaTack™ |
Primary outcome
Change in Pain
Time frame: Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.
Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
6 secondary outcomes
Number of Participants With Hernia Recurrence
Time frame: Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported
Successful Mesh Fixation at the Time of Surgery.
Time frame: Time of surgery.
Incidence of Successful Peritoneal Closure (TAPP Repairs Only)
Time frame: Time of surgery.
Quality of Life as Measured by the Carolinas Comfort Scale (CCS).
Time frame: Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).
Time frame: Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Safety as Measured by the Incidence of Adverse Events.
Time frame: Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John S Roth, Medicine principal investigator
University of Kentucky College of Medicine
6 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® and AbsorbaTack™ in people with Hernia and Inguinal Hernia, run by Advanced Medical Solutions Ltd. at 6 sites in United States.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain (time frame: Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.). 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 11 Jan 2024.