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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiquiBand FIX8® | Experimental | LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquiBand FIX8® | Device | An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
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Inclusion Criteria:
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;
Is willing and able to comply with the protocol assessments at time of surgery and during the post surgical follow up period
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| John S Roth, Medicine | University of Kentucky College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Weston | Florida | 33331 | United States | ||
| University of Kentucky College of Medicine UK Medical Center |
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Between August 2019 and December 2021, 329 patients were screened and consented for laparoscopic groin (femoral and inguinal). Of those Subjects 142 were randomized to LiquiBand Fix8 and 142 were randomized to AbsorbaTack for mesh fixation and peritoneal closure (in the case of TAPP).
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| ID | Title | Description |
|---|---|---|
| FG000 | LiquiBand FIX8® | Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to LiquiBand FIX8®, for mesh fixation and peritoneal closure (in the case of TAPP). |
| FG001 | AbsorbaTack™ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2021 |
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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.
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Randomization to either Investigational or control device will occur at the surgery visit. The patients will be blinded to their randomly assigned treatment device prior to surgery and during the follow up period following surgery. While it is not possible to blind investigators/staff members to the treatment device used, Investigators and staff members will not learn of randomized device until immediately prior to use of device, so as to maintain subject blinding prior to the hernia repair. Investigators and staff members will be asked to maintain subject blinding through the course of the follow up visits so as to not bias subject feedback on applicable study assessments. Patients will receive the same standard of care prior to, during and following surgery regardless of randomized device assignment, and therefore will not be able to individually determine what device they have been randomized to.
| AbsorbaTack™ | Device | An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. |
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| 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. | 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. | 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. | 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. | 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™). | Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery |
| Lexington |
| Kentucky |
| 40506 |
| United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43221 | United States |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to AbsorbaTack™ for mesh fixation and peritoneal closure (in the case of TAPP).
| COMPLETED |
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| NOT COMPLETED |
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The analysis population n=284 Subjects, were randomized and enrolled into the investigational study and formed the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | LiquiBand FIX8® | Groin Hernia Study Arm with LiquiBand FIX8® as treatment |
| BG001 | AbsorbaTack™ | Groin Hernia Study Arm with AbsorbaTack™ as treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population defined as all enrolled subjects. All patients for whom VAS measurements were recorded at Baseline and 6 month post surgery | Posted | Mean | Standard Deviation | score on a VAS scale | 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. |
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| Secondary | 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? | ITT population defined as all enrolled subjects. All patients who attended their follow up visit and underwent a physical examination where possible, or alternatively with self-assessment for hernia recurrence. | Posted | Count of Participants | Participants | Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported |
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| Secondary | 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. | All Subjects who underwent surgery with LiquiBand FIX8® or control | Posted | Count of Participants | Participants | Time of surgery. |
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| Secondary | 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. | ITT Population. Successful peritoneal closure at time of surgery was measured in all subjects undergoing TAPP hernia repair. | Posted | Count of Participants | Participants | Time of surgery. |
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| Secondary | 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. | ITT population defined as all enrolled Subjects. All patients for whom a CCS questionnaire was completed prior to surgery and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post surgery. | Posted | Mean | Standard Deviation | score on a scale | Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery |
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| Secondary | 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. | ITT population defined as all enrolled subjects. All patients for whom VAS measurements were recorded at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post-surgery | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Secondary | 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™). | Posted | Number | Adverse Events | Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery |
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Adverse Event data was collected from time of randomization through 12 month follow up
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LiquiBand FIX8® | Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to LiquiBand FIX8®, for mesh fixation and peritoneal closure (in the case of TAPP). | 1 | 142 | 11 | 142 | 28 | 142 |
| EG001 | AbsorbaTack™ | Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to AbsorbaTack™, for mesh fixation and peritoneal closure (in the case of TAPP). | 0 | 142 | 16 | 142 | 49 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cerebro Vascular Accident | Vascular disorders | MedDRA | Systematic Assessment |
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| Cervical vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Dizziness | General disorders | MedDRA | Systematic Assessment |
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| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Incisional Hernia | General disorders | MedDRA | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Leiomyosarcoma | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Medical device site infection | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Prostate cancer metastatic | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Tooth Abcess | Infections and infestations | MedDRA | Systematic Assessment |
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| Urethral injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary tract injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Urosepsis | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Vomiting | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Groin Pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Warburton, Senior Clinical Research Associate | Advanced Medical Solutions | 07791742957 | tina.warburton@admedsol.com |
| Dec 19, 2023 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D006552 | Hernia, Inguinal |
| D006550 | Hernia, Femoral |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
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