In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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
Followup Visits and Length of Followup
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).
