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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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AspireAssist Post-Approval Study

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Study Status Terminated
Application Number P150024 / PAS002
Date Current Protocol Accepted 01/15/2019
Study Name 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
-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 10 (minimum) and 50 (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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 17 (5%) enrolled patients out of 323 planned
Actual Number of Sites Enrolled 6 sites out of 15 planned
Patient Follow-up Rate 47% (8/17) for a 3.4 person-years of follow-up. No patient was
followed for the required 5-year period (three patients were followed
for 4.1 years, one 3.8, one 3.5, one 3.0, one 2.8, and one 1.8 years)
Study Strengths & Weaknesses Weaknesses: The study was terminated early due to withdrawal of the PMA on April 15, 2022. Results cannot be interpreted in relation to the
study plan due to low enrollment.
Strengths: None
Recommendations for Labeling Changes No labeling is necessary because the sponsor withdrew the PMA on
04/15/22, and as a result the PAS was terminated early on April 15,
2022, due to challenging enrollment

AspireAssist Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
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
interim report 08/02/2017 08/02/2017 On Time
18 month report 12/13/2017 12/12/2017 On Time
two year report 06/14/2018 06/12/2018 On Time
three year report 06/14/2019 06/12/2019 On Time
42 month report 12/14/2019 12/17/2019 Overdue/Received
four year report 06/13/2020 06/15/2020 Overdue/Received
54 month report 12/14/2020 02/09/2021 Overdue/Received
5 year report 06/14/2021 07/09/2021 Overdue/Received
interim report 12/13/2021 12/13/2021 On Time
final report 06/14/2022 05/06/2022 On Time

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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