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| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P180024 / PAS001 |
| Date Original Protocol Accepted |
04/16/2019
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| Date Current Protocol Accepted |
|
| Study Name |
ENDObesity PAS
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| Device Name |
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
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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 |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multicenter, open-label study conducted in the United States. A total of 260 patients will be enrolled at up to 15 sites. Patients who meet the inclusion/exclusion criteria and sign the informed consent to participate the study will be enrolled. Patients will be followed for 12 months or until the device removal, whichever occurs earlier. Patients who lost at least 5% TBL will be followed for an additional 6 months after TPS removal for evaluation of weight loss maintenance.
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| Study Population |
Male and female patients, greater than or equal to 22 years of age, with a BMI of 35.0 to 40.0 kg/m2, inclusive, or a BMI of 30.0 to 34.9 kg/m2 with at least one obesity-related comorbidity.
Key inclusion criteria include:
1. Age 22 years and older
2. BMI 30-40 kg/m2, inclusive, or a BMI of 30.0 to 34.9 kg/m2 with at least one obesity-related comorbidity
3. History of failure of medically or commercially supervised weight loss program
4. Female patients of childbearing potential willing to avoid pregnancy during the course of treatment
5. Willing and able to comply with study procedures and study visits
6. Willing and able to comply with lifestyle modification program for two years
Key exclusion criteria include:
1. Contraindicated for use of the TPS device per Instructions for Use
2. Known hormonal or genetic cause for obesity
3. History of gastropareses
4. History of pancreatitis
5. History of portal hypertension, cirrhosis, and/or esophageal varices
varices
6. A history of cardiac arrhythmia, ischemic heart disease, myocardial infarction or chronic heart failure
7. History of cerebrovascular disease, transient ischemic attack, or stroke
8. A history of malignancy except non-melanoma skin cancer
9. Continuous therapy with known ulcerogenic medication (e.g., aspirin greater than 81 mg/day, NSAIDs)
10. On anticoagulation or antiplatelet therapy (e.g., Coumadin, Warfarin, Heparin, Pradaxa, Xarelto, Plavix)
11. Unable to take proton pump inhibitor (a daily 40+ mg of Omeprazole or equivalent), or where addition of PPI may cause adverse drug interaction with patient’s medication or interruption of treatment
12. History or severe psychiatric illness
13. Current smoker or user of nicotine product or smoking cessation within one year
14. Current abuse of drug or alcohol or past treatment for substance abuse
15. Diagnosis of bulimia nervosa or binge eating disorder
16. Any anatomical or endoscopic abnormalities/ characteristics that would preclude safe use of the TPS
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| Sample Size |
260 patients will be enrolled at up to 15 sites
|
| Key Study Endpoints |
Primary Endpoint: Proportion of patients with device- or procedure-related serious adverse events
Secondary Endpoints:
Mean percent total body weight loss (%TBL)
Proportion of patients who achieve at least 5% and 10% TBL
Percent excess weight loss (%EWL)
Change of BMI from baseline
Proportion of patients who achieve at least one obesity class reduction
Proportion of patients with device residence time less than 12 months
Change in comorbid conditions:
The components of metabolic syndrome: blood pressure, glucose, HDL-C, triglycerides and waist circumference
Other obesity related metabolic indicators: insulin, and insulin resistance (as estimated by HOMA), total cholesterol, and LDL-C.
Weight loss maintenance at 3 and 6 months post TPS removal
Other Safety Endpoints:
Incidence of device-related adverse events
Incidence of procedure-related adverse events
Incidence of upper GI ulcers
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| Follow-up Visits and Length of Follow-up |
Treatment phase: 12 months or until the device removal, whichever occurs earlier
Weight loss maintenance phase: Additional 6 months for patients who lost at least 5%TBL prior to TPS Removal
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