(True You as participating site)
The Spatz3 Adjustable Balloon System is the world’s first and only adjustable gastric balloon. The Spatz Balloon was approved by the FDA in October 2021, after demonstrating an 84% success rate and 15% average total body weight loss, results that far exceeded every non-adjustable balloon in non-comparative studies.
True You is excited to participate in the Spatz3 Post Approval Study, designed to contribute to the continuing evaluation and reporting of the safety and effectiveness of the Spatz3 Intragastric Balloon. As a participating research location, True You can offer a non-surgical procedure that helps patients jump-start weight loss and keep it off. With the help of our amazing patients, we have reached our enrollment goal at both our Atlanta and Cary locations! Through their valuable participation, our patients will help inform patient labeling, balloon improvements, and inform the field.
Study status: enrollment complete; awaiting study findings
