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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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LiquiFix Post-Approval Study


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General
Study Status Ongoing
Application Number /
Requirement Number
P220024 / PAS001
Date Original Protocol Accepted 07/28/2023
Date Current Protocol Accepted  
Study Name LiquiFix Post-Approval Study
Device Name LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Clinical Trial Number(s) NCT04009213 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
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)
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
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.
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.
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
Interim or Final Data Summary
Interim Results Safety Results:
LIQUIFIX FIX8™
• 30 day: 92.1% (n=116) of patients were evaluated. 0.9% (n=1) was readmitted for gastrointestinal complications and underwent a reoperation for bowel obstruction and 0.9% (n=1) was re-admitted and re-operated for bleeding complication. There was 1 (0.9%) recurrence recorded and 1 (0.9%) re-operation for hernia recurrence. 1.7% (n=2) had a surgical site infection. 9.5% (n=11) experienced a surgical site occurrence (1 wound cellulitis and 10 seroma).
• 1 year: no surgical site infections or occurrences. 1% (n=1) re-operation for recurrence at 1 year.
• 2 year: 2.9% (n=1) surgical site infections and 2.9% (n=1) surgical site occurrence
LIQUIFIX Precision™
• 30 day: 55.6% (n=10) of patients were evaluated. There were 0% recurrence recorded. There were 0% surgical site infection and 10% (n=1) experienced a surgical site occurrence (seroma)
• 1 year: no follow-up available yet

Effectiveness Results
LIQUIFIX FIX8™
30 day: 0.9% (n=1) underwent a reoperation for bowel obstruction, 0.9% (n=1) for post-operative bleeding and 0.9% (n=1) underwent a reoperation for recurrence.
• 1 year: 1% (n=1) reoperation for recurrence
• 2 year: no reoperation for recurrence
LIQUIFIX Precision™
• 30 day: no readmission or reoperation
Actual Number of Patients Enrolled 144
Actual Number of Sites Enrolled This study is based on data already collected in the ACHQC.
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 (approximately 103), data analysis will be performed. To review study progress, a patient progress report will be extracted from ACHQC every 6 months from the date of the PMA approval letter, until all the required data is collected.
Currently 144 patients are enrolled (126 LIQUIFIX FIX8™ and 18 LIQUIFIX Precision™). 116 LIQUIFIX FIX8™ patients performed 30-day follow-up, with 91 completing the 1-year recurrence follow up and 86 patients completing the 2-year recurrence follow up. 10 LIQUIFIX Precision™ patients performed 30-day follow-up, and none had completed the 1-year recurrence follow-up or reached 2-year follow-up.


LiquiFix Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/01/2023 12/01/2023 On Time
1 year report 06/01/2024 05/31/2024 On Time
18 month report 11/30/2024 11/29/2024 On Time
2 year report 06/01/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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