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|
| 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
|
| 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
|
| 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
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