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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070009 / PAS001 |
| Date Original Protocol Accepted |
09/28/2007
|
| Date Current Protocol Accepted |
09/09/2008
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| Study Name |
Realize PAS
|
| Device Name |
REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
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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 |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, single-arm, multi-center study designed to look at the long-term re-operation rates seen with the Swedish Adjustable Gastric Band.
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| Study Population |
Study population: Subjects are between the ages of 18 and 60 years old who have been diagnosed with morbid obesity and considered appropriate candidates for surgical weight reduction. Indication: Patients with one or more significant medical conditions related to obesity for which the subject is being treated, and which are generally expected to be improved by weight loss. Body Mass Index (BMI) must be greater than or equal to 35 kg/m2 and less than or equal to 40 kg/m2.
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| Sample Size |
300 patients, 8 sites
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| Key Study Endpoints |
The primary endpoint is the re-operation rate (including band revisions, band replacements, and explants) in years four and five post-implant. Secondary endpoints are: HbA1c levels, serum lipid levels, amount of excess body weight loss, quality of life measured by SF-36, Beck Depression Inventory scale score, adverse event rate, severe adverse event rate
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed for five years. During year 1 following implant, evaluations take place at 1, 2, 4, 6, 8, and 10 months. Evaluations will then take place at 12 months, 24 months, 36 months, 48 months, and 60 months.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
303
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| Actual Number of Sites Enrolled |
8
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| Patient Follow-up Rate |
77%
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| Final Safety Findings |
The primary safety goal of this study was to determine the reoperation rate (band revision, band replacement, and explants resulting from Serious Adverse Events (SAEs)) of gastric banding at 4 and 5 years post implant. The safety success criterion for this study was an observed device-related reoperations rate significantly lower than 8% for Years 4 and 5 of the study. The observed reoperation rate in the post-approval study was 8.9% with an upper bound 95% confidence interval of 12.08%, which results in failure to reject the null hypothesis (H0: Reoperation rate ? 8%). Therefore, there is no evidence that the reoperation rate is less than 8%.
The most commonly occurring AE related to the study device was GI disorders with 1,117 events experienced by 246 (81.2%) subjects. Of all the adverse events that occurred in Years 4 and 5 of the study, the most commonly occurring AE related to the study device was GI disorders with 289 events experienced by 155 (51.2%) subjects. Overall, gastroesophageal reflux disease (14.2%), vomiting (13.5%), esophageal dilation (8.9%), dysphagia (7.9%), and gastric dilatation (6.3%). The overall explant rate was 8.9% with a 95% CI range of 6.0% to
12.08%.
Most Frequently Occurring Device Related Serious Adverse Events include: device migration (9.2%), catheter related complication (5.0%), cholelithiasis (4.3%), cholecystitis (2.6%), and gastric dilatation (2.3%) were the most common SAEs reported throughout the entire study.
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| Final Effect Findings |
As a result of the reduction in BMI, important and statistically significant reductions in the lipid profile were achieved and were reported since the first year of follow-up including reductions in LDL, triglycerides, and HbA1c values, which were maintained throughout the remainder of the study. There was a statistically significant change in BMI values between each yearly time point and the value at screening. However, there was not a statistically significant change appreciated in the total cholesterol levels. The following are detailed results at 5-years post- surgery in the ITT population:
? %EWL was 35.6 ± 26.84;
? Mean reduction in BMI (kg/m2) was -7.0 ± 5.45 (95% CI: -7.7 to -6.3);
? Mean reduction in absolute weight (lb) and mean % in weight reduction (%) was -43.1 ±
32.5 (95% CI: -47.3 to -39.0), and 16.0 ± 11.9 (95% CI: 14.5 to 17.6) respectively;
? The Physical Component score and the domain scores for SF-36 showed improvement at every post-surgery visit;
? The total transformed score and the domain scores for the IWQOL-Lite showed improvement at every post-surgery visit in the CI-07-0006 cohort;
? Mean reduction in HbA1c (%) was -0.22 ± 0.823 (95% CI: -0.33 to -0.11), which was statistically significant;
? Mean increase in HDL (mg/dL) was 9.3 ± 11.51 (95% CI: 7.7 to 10.8), which was statistically significant;
? Mean reduction in LDL (mg/dL) was -7.3 ± 31.90 (95% CI: -11.6 to -3.0), which was statistically significant;
? Mean reduction in total cholesterol (mg/dL) was -2.0 (95% CI: -7.8 to 2.0), which was not
statistically significant; and
? Mean reduction in triglycerides (mg/dL) was -28.2 ± 110.15 (95% CI: -42.7 to -13.7), which was statistically significant.
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| Study Strengths & Weaknesses |
Enrollment was successful: A sample size of 300 was expected and a total of 303 were studied.
A five-year follow-up was achieved providing long-term safety and effectiveness data. Weaknesses:
No concurrent comparison group, which limits interpretation of the results. Based on this one study, statements comparing the device to alternative treatments cannot be
made.
A 77% follow-up rate was attained. Loss to follow-up limit the interpretation of the study results. The subjects that remain in the study may be different to those that were lost, and therefore, the generalizability of results can be limited.
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| Recommendations for Labeling Changes |
PAS study data must be added to the labeling including: description of the study design and methods, and the new safety information through 5 years of follow-up.
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