f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • 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...


           

Spatz3 Post-Approval Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
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
Interim Results There was a total of 105 adverse events among 36 (54.5%) patients. None of them were serious except one appendicitis that required surgery. This adverse event was unrelated to the device or the procedure.
Actual Number of Patients Enrolled 93 patients enrolled; 66 patients implanted
Actual Number of Sites Enrolled 22 sites initiated, 10 sites enrolling patients
Patient Follow-up Rate 98%


Spatz3 Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/15/2022 04/15/2022 On Time
1 year report 10/15/2022 10/13/2022 On Time
18 month report 04/15/2023    
2 year report 10/15/2023    
3 year report 10/14/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

-
-