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| General |
| Study Status |
Progress Adequate |
| Application Number |
P100049 / PAS002 |
| Current Plan Approved |
06/22/2012
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| Study Name |
OSB Lead-Enrollment Study
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Design Description |
Prospective, multicenter, single‐arm study, with patients as their own control.
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| 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)
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| 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.
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| 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
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| 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).
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