|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P190012 / PAS001 |
| Date Original Protocol Accepted |
10/15/2021
|
| Date Current Protocol Accepted |
|
| Study Name |
Spatz3 Post-Approval Study
|
| Device Name |
Spatz3 Adjustable Balloon System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a single-arm, multi-center, US-based new enrollment study. The objective is to obtain data regarding the safety and effectiveness of the Spatz3 Adjustable Balloon System in the post-market space. This is an all-comer study.
|
| Study Population |
Adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program
|
| Sample Size |
The sample size is based on the endpoint of deflation with migration. 467 subjects are needed to achieve
80% power with a lower one-sided Z test assuming a Ho rate of 1%, observed rate of 0.03%, and
alpha=0.025. Assuming a lost-to-follow-up rate of 15%, 537 subjects will need to be enrolled.
|
| Key Study Endpoints |
The primary study endpoint is to demonstrate that the rate of device or procedure related SAEs is less than 8% at 8 months.
The secondary study endpoint is to demonstrate that the mean percent TBL in the effectiveness cohort is not less than 14% at eight months.
Other study endpoints (through 32 weeks) include:
• weight loss measured by percent excess weight
loss (%EWL)
• device- and/or procedure-related adverse
events with respect to severity, relationship to
the device and/or procedure, and rate of
occurrence
• Rates for the following events:
o gastric ulcers,
o esophageal injury,
o spontaneous hyperinflation*,
o microorganism growth (inside and
outside of the balloon)*,
o acute pancreatitis,
o aspiration,
o esophageal perforation,
o gastric perforation,
o bowel perforation,
o death,
o early explants,
o deflations,
o deflations with migrations, and
o deflations that are vomited
*Culturing data will be collected for balloon that spontaneously hyperinflate or have microorganism growth inside and/or outside of the balloon
Weight maintenance measured by percent excess weight loss (%EWL) and %TBL at 6 months post-explantation will be assessed on an effectiveness
cohort - patients who achieved at least 5% TBL at the end of the 8 month treatment period.
|
| Follow-up Visits and Length of Follow-up |
8 months or 14 months for patients who achieve at least 5% TBL by the end of the 8 month treatment period
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
537
|
| Actual Number of Sites Enrolled |
23
|
