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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Extended f/u of premarket cohort

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Application Number P100049 / PAS001
Current Plan Approved 06/22/2012
Study Name OSB Lead-Extended f/u of premarket cohort
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 The study is a prospective, multi-center, single arm clinical study that will be conducted in the United States and Europe.
Study Population Description Subjects ages > 18 or Age of Majority according to Law in states or countries where 18 is considered a minor and < 75 years seeking intervention for GERD who meet the study inclusion / exclusion criteria are eligible for this study. The study will consist of all IDE patients (100 subjects at the beginning of the IDE) available at the end of the IDE study (90 by time of the panel) that may be implanted with the device. Subjects entering study will be at least partially responsive to medical therapy (proton pump inhibitors) for their GERD symptoms and have tested positive (abnormal) in esophageal pH testing.

Sample Size The study will continue to follow the 100 patients available in the IDE pivotal study. There were 90 patients available at time of panel discussion.
Data Collection Primary safety endpoint:

The primary safety endpoint is the rate of occurrence for serious device and procedure related adverse events. The primary safety end-point will be assessed by reporting all adverse events and by estimating the rate of serious device and procedure related adverse events through 12 months post implantation. Safety will also be evaluated by endoscopy to assess the mucosa and abdominal/chest X-ray evaluations to verify device location at 12 months post implantation.

Primary effectiveness endpoints:

Reduction in total distal esophageal acid exposure time defined by esophageal pH testing. Testing will be performed with subjects off PPIs. The subject¡¯s baseline pH acid exposure time will serve as the control and be compared to the subject¡¯s pH acid exposure time 12 months post implantation.

Success criteria ¨C At least 60% of subjects will have normalized or improved by at least 50% in total distal acid exposure.

Secondary effectiveness endpoints:

Subjects GERD-HRQL (Health Related Quality of Life) scores will be assessed off all GERD medications. The subject¡¯s baseline GERD-HRQL score will serve as the control and be compared to the subject¡¯s GERD-HRQL 12 months post implantation.

Success criteria - At least of subjects will have a reduction in total GERD-HRQL scores.

Subject¡¯s average daily dose of PPI will be evaluated. The subject¡¯s baseline average daily dosage will serve as the control and be compared to the subject¡¯s average daily dosage 12 months post-procedure.

Success criteria - At least of subjects will reduce their average daily PPI dosage .

Follow-up Visits and Length of Follow-up The length of follow up will be 60 months post-implantation.

The follow up assessments will take place at yearly intervals up to the end of the study at 60 months.

Final Study Results
Number of Patients 100
Number of Sites 14
Follow-up Rate 85/100 (85%)
Safety Findings 10 serious adverse events were reported in 7 subjects. The serious SAE rate was 7.0% with an upper confidence limit of 15.2% at 60 months.
Effect Findings 83.3% of subjects had at least a 50% reduction in their 60 month total GERD-HRQL score when compared to baseline (95% confidence interval with lower confidence limit = 68.7%).
Strengths & Weaknesses Strengths: This study had a high five year follow-up rate of 85 out of 100 subjects or 85%, which met the requirement of 80% specified in the condition of approval. It is important for a longitudinal study to

have a high follow-up rate, in order to avoid potential bias and generate valid conclusions.

Weaknesses: There was no comparator group in this study. The mean subject body mass index was 27.9 kg/m2 (range 19.8, 34.7). Therefore, the effectiveness of this device for patients with BMI over 35 is unknown.

Label Changes None. There are no new safety or effectiveness concerns since the approval of the current labeling

OSB Lead-Extended f/u of premarket cohort Schedule

Report Schedule
Date Due
FDA Receipt
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-final report 03/22/2015 12/15/2014 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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