|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
P150024 / PAS002 |
Date Original Protocol Accepted |
12/15/2016
|
Date Current Protocol Accepted |
01/15/2019
|
Study Name |
AspireAssist Post-Approval Study
|
Device Name |
AspireAssist
|
Clinical Trial Number(s) |
NCT01766037
|
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 Objectives |
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 |
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 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%).
|
Key Study Endpoints |
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
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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)
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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
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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
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