• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

OSB Lead-AspireAssist Post-Approval Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Inadequate
Application Number P150024 / PAS002
Date Current Protocol Accepted 12/15/2016
Study Name OSB Lead-AspireAssist Post-Approval Study
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 The study is a prospective new enrollment registry study of subjects implanted with the A-Tube, participating in AspireAssist therapy who provide consent to participate in the study.
Study Population Description Inclusion Criteria:

1. Subjects eligible for AspireAssist:

-Measured BMI of 35.0-55.0 kg/m2 at the time of screening

-22 years of age at time of screening

2. Subjects willing to comply with follow-up evaluations for

5 years post-implant, 2 years post explant if therapy is

ended within 5 years, and provide written informed consent



Exclusion Criteria:

1. Subjects currently enrolled in the Aspire PATHWAY

clinical study

2. Subjects currently participating in another weight loss therapy

3. Subjects contraindicated for AspireAssist:

-Previous abdominal surgery that significantly increases the medical risks of gastronomy tube placement

-Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease

-History of refractory gastric ulcers

-Ulcers, bleeding lesions, or tumors discovered during endoscopic examination

-Uncontrolled hypertension (blood pressure>160/100)

-History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiringmedications, or NYHA class III or IV heart failure.

-Coagulation disorders

-Anemia

-Pregnant or lactating

-Diagnosed bulimia or diagnosed binge eating disorder

(using DSM criteria)

-Night Eating Syndrome

-Chronic abdominal pain that would potentially complicate the management of the device

-Physical or mental disability, or psychological illness that could interfere with compliance with the therapy

-At high risk of having a medical complication from the endoscopic procedure or the AspireAssist weight loss program for any reason including poor general health or severe organ dysfunction such as cirrhosis or renal dysfunction

Sample Size Consecutive patients receiving the device will be invited to participate in the PAS. A total of 323 subjects implanted with the A-Tube per device labeling will be enrolled, at 15 sites. Each site will enroll between 15 (minimum) and 35 (maximum) subjects. With an estimated attrition rate of 20%, 259 subjects should complete the 5 years of follow-up, and will provide 80% power to reject the null hypothesis, assuming the serious adverse event rate is the same as in previous studies (3%).
Data Collection Primary Safety Endpoint:

-5 year rate of Serious Adverse Events (SAEs), defined as any Adverse Event (AE) that is fatal, immediately life- threatening, requires inpatient hospital admission for more than 24 hours due to a device or therapy-related SAE,

causes permanent or significant disability, or requires medical or surgical intervention to prevent permanent sequelae. All AEs will be adjudicated by a Safety Adjudication Committee (SAC).



Secondary Effectiveness Endpoints:

-Compliance with appropriate use of AspireAssist system: Weight loss, % Excess Weight Loss (EWL), and % Total Body Loss (TBL), and connector counts will be assessed. Excess weight will be determined from ideal body weights based on a BMI = 25kg/m2

-Percentage of patients achieving a 25% EWL

-Percentage of patients who have a positive or negative change in medications related to comorbidities (hypertension, diabetes, and dyslipidemia)



Secondary Safety Endpoints:

-Percentage of patients with AEs related to eating disorders

-Five-year rate of incidence, duration and severity of AEs related to stoma issues including infection (bacterial or fungal) and granulation tissue

Follow-up Visits and Length of Follow-up Follow up of implanted subjects will be 5 years, and any explanted patients will be followed for an additional 2 years from the time of explant.


OSB Lead-AspireAssist Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/13/2016 12/14/2016 Overdue/Received
one year report 06/14/2017 06/12/2017 On Time
unscheduled report 08/02/2017 08/02/2017 On Time
18 month report 12/13/2017    
two year report 06/14/2018    
three year report 06/14/2019    
four year report 06/13/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-