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

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ENDObesity PAS


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General
Study Status Study Pending
Application Number P180024 / PAS001
Date Current Protocol Accepted  
Study Name ENDObesity PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description 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
Sample Size 260 patients will be enrolled at up to 15 sites
Data Collection 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
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


ENDObesity PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/15/2019    
one year report 04/15/2020    
18 month report 10/14/2020    
two year report 04/15/2021    
three year report 04/15/2022    
four year report 04/15/2023    
five year report 04/14/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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