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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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Enrollment Study


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General
Study Status Completed
Application Number P100049 / PAS002
Date Current Protocol Accepted 01/29/2018
Study Name Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multicenter, single-arm study, with patients as their own control.
Study Population Description The study population will consist of patients who have signed the informed consent form, meet the eligibility requirements and have been implanted with the LINX device. Each patients baseline assessments will serve as the comparator post-implant to evaluate the treatment effect.
Inclusion Criteria
- Patient is a candidate for treatment with the LINX Reflux Management System.
- Patient has provided written informed consent for participation in the post-approval study.
- Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
- Patient has been diagnosed with GERD as defined by abnormal pH testing.
- Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux
Exclusion Criteria
- Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials
- Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months (e.g. life expectancy <5 years)
Sample Size A total of 200 patients will be implanted with the LINX device and followed per protocol.
At least 20 study centers throughout the US will participate. The study centers will include pivotal IDE centers and at least 10 centers with no prior LINX experience.
Data Collection Device related serious adverse events (SAEs) evaluated at 6 months, 12 months and then repeated annually through 60 months. No formal statistical hypothesis test will be conducted. Number of events, number of study patients with event, and the percent of study patients implanted with an event will be summarized. A sufficient number of study patients will be enrolled and followed to ensure a high probability of the detection of rare adverse events through 5 years of follow up, defined as an expected incidence rate of implanted study patients.

At least of evaluable study patients will have at least a reduction in total GERD HRQL score off PPIs, as indicated by the lower bound of a confidence interval. Endpoint to be evaluated at 6 months, 12 months and then repeated annually through 60 month.

Evaluated at 6 months, 12 months and then repeated annually through 60 months.
Safety
- Incidence rate of device- and/or procedure-related adverse events
Efficacy
- pH measurements: Total % time pH, DeMeester components and DeMeester score. (NOTE: not done at 6 months)
- Symptoms: From the Foregut Symptom Questionnaire (FSQ), the frequency and severity of regurgitation and % patients reporting extra-esophageal symptoms
- GERD medications: % patients free from daily use of acid suppression therapy
Follow-up Visits and Length of Follow-up The length of follow up will be 60 months post-implantation.

Visits are at screening/baseline, implant/discharge, 6-months and annually with last visit scheduled at the end of the study (60 months).

Interim or Final Data Summary
Actual Number of Patients Enrolled 200 patients enrolled and implanted
Actual Number of Sites Enrolled 22 sites obtained IRB approval
Patient Follow-up Rate 5-Year follow-up rate is 68% (136/200)
Final Safety Findings The 5-year rate of device and/or procedure-related SAEs (primary safety endpoint) was 5.5%. The rate of device-related SAEs at 36 months was 4.5% (95% CI: 2.1%, 8.4%), which did not exceed the upper confidence limit (12.6%) reported through 12 months in the IDE study. The rate of all device and/or procedure related adverse events (including serious and non-serious AEs) was 26.5%. Rate of device explant was 13% and the rate of device erosion was 2.0%. Overall, the types and rates of safety events reported in the PAS were comparable to what was reported in the IDE premarket study with the exception of device explants, which occurred in nearly twice as many PAS patients compared to IDE patients (13% vs. 7%).
Final Effect Findings For the primary effectiveness endpoint (total GERD-HRQL Score at each follow-up visit), 83-89% of patients reported a successful reduction in GERD symptoms, 6 months to 5 years after device implant. In addition, there was clinical improvement for the other key indicators of reflux control when compared from baseline in secondary effectiveness measures including: esophageal acid exposure, extra-esophageal symptoms, severity and frequency of heartburn and regurgitation, and PPI usage at 6 months and all subsequent follow-up visits through 60 months.
Study Strengths & Weaknesses A key strength of this study is the long, 5-year follow-up and the demonstration of longer-term treatment safety and effectiveness of LINX treatment. However, given that 32% of the PAS cohort (64 patients) were not included in the 5-year follow-up, there is concern about the possibility of patient selection bias leading to overestimated treatment effects.
Recommendations for Labeling Changes FDA recommends updating the labeling with the final PAS results


Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/20/2012 09/20/2012 On Time
one year report 03/22/2013 03/26/2013 Overdue/Received
18 month report 09/20/2013 09/20/2013 On Time
two year report 03/22/2014 03/18/2014 On Time
three year report 03/22/2015 03/17/2015 On Time
four year report 03/21/2016 03/18/2016 On Time
five year report 03/21/2017 03/21/2017 On Time
six year report 03/21/2018 03/20/2018 On Time
seven year report 03/21/2019 03/15/2019 On Time
eight year report 03/20/2020 03/19/2020 On Time
final report 03/22/2021 04/30/2021 Overdue/Received


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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