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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220024 / PAS001 |
| Date Original Protocol Accepted |
07/28/2023
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| Date Current Protocol Accepted |
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| Study Name |
LiquiFix Post-Approval Study
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| Device Name |
LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
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| Clinical Trial Number(s) |
NCT04009213
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
A Post Approval Observational study using real-world data (RWD). The objective of the study is to evaluate the long-term safety of the LIQUIFIX implanted adhesive using real-world evidence methods through the ACHQC. Also see figure below (4.6)
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| Study Population |
Patients for this study will include all USA patients undergoing open or laparoscopic groin (inguinal/femoral) hernia repair, recruited from ACHQC participating institutions whose mesh fixation and peritoneal closure (in TAPP repair) is undertaken with the LIQUIFIX cyanoacrylate adhesive. As the data will be collected using real world evidence, sex, age, race will be most frequently observed in male, white, aged population and not further dictated by AMS. Inguinal hernias are the most common form of groin hernia and have a 9:1 male predominance, with a higher incidence among men over the age of 40 [1][2]. Additionally, white men have 2-times higher rate of incidence of inguinal hernia than black men [1]. Femoral hernias account for only 2% to 4% of all groin hernias and are more likely to occur in women than in men [3].
Any concomitant procedures will also be captured as part of the data collection.
A source comparator group will be used. This group will be concurrent propensity match scored and generated via ACHQC and will consist of patients where an alternative mesh fixation and peritoneal closure (for TAPP repair) was used. There will be a separate comparator group for each device specification (open and laparoscopic). Each comparator group has been selected based on current state of the art devices for each technique application:
For LIQUIFIX Fix8™ - Two groups of controls, Absorbable and Permanent Tackers will be used as the comparator
For LIQUIFIX Precision™ - Sutures, Staples and Tackers (absorbable and permanent) will be used as the comparator
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| Sample Size |
Number of subjects: n = 206 for LiquiFix Precision™ and n = 103 for LiquiFix Fix8™ or the number of patients at who are registered into the ACHQC at one year, whichever is the largest.
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| Key Study Endpoints |
Primary: The incidence of hernia recurrence in patients following groin hernia repair using LIQUIFIX will be measured using a concurrent propensity match control (via ACHQC) at 30 days and annually for a minimum of 2 years post-surgery.
Secondary 1: The incidence of reoperation in patients following groin hernia repair using LIQUIFIX will be measured using a concurrent propensity match control (via ACHQC) at 30 days and annually for a minimum of 2 years post-surgery.
Secondary 2: The incidence of surgical site infection in patients following groin hernia repair using LIQUIFIX will be measured using a concurrent propensity match control (via ACHQC) at 30 days and annually for a minimum of 2 years post-surgery.
Secondary 3: Levels of reported pain in patients following groin hernia repair using LIQUIFIX will be measured using a concurrent propensity match control (via ACHQC) at 30 days and annually for a minimum of 2 years post-surgery,
Secondary 4: Reported Quality of life in patients following groin hernia repair using LIQUIFIX will be measured using a concurrent propensity match control (via ACHQC) at 30 days and annually for a minimum of 2 years post-surgery
Secondary 5: The incidence of post operative complication rates following groin hernia repair using LIQUIFIX will be measured using a concurrent propensity match control (via ACHQC) at 30 days and annually for minimum 2 years post-surgery.
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| Follow-up Visits and Length of Follow-up |
Passive long-term follow up rates including email-based PRO engagement and routine clinical long-term follow up result in an estimated 20% completion at 2 years. Subjects follow up data collection intervals will occur at 30 days and annually for a minimum of 2 years post-surgery
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
30-day: 95% (n=95) patients were evaluated. 1.1% (n=1) was re-admitted for gastrointestinal complications and underwent a reoperation for bowel obstruction. 1.1% (n=1) had a surgical site infection, and 9 patients experienced a surgical site occurrence (1 wound cellulitis and 8 seroma). Four (4) other complications were reported, however, details of this were not available within the registry at present. No deaths were recorded.
1 year: no surgical site infections or occurrences (these patients are from the IDE study G190018)
2 year: no surgical site infections or occurrences (these patients are from the IDE study G190018)
Effectiveness Results:
30 day: 1.1% (n=1) underwent a reoperation for bowel obstruction.
1 year: no reoperation for recurrence (these patients are from the IDE study G190018)
2 years: no reoperation for recurrence (these patients are from the IDE study G190018)
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| Actual Number of Patients Enrolled |
100
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| Actual Number of Sites Enrolled |
This study is based on data already collected in the ACHQC.
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| Patient Follow-up Rate |
For the purpose of this study, Subjects follow up data collection intervals will occur at 30 days and annually for a minimum of 2 years post-surgery. Once the desired number of patients required to fulfil this study are collected, i.e.minimum n= 206 for LiquiFix Precision™ and n= 103 for LiquiFix Fix8™ or the number of patients at who are registered into the ACHQC at one year, whichever is the largest, as well as continued follow-up of the available IDE patients currently enrolled in ACHQC (app
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