NCT05086302

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

A Postmarket Study for Continuing Evaluation and Periodic Reporting of the Safety and Effectiveness of the Spatz3 Intragastric Balloon

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 537 (actual)
• Sponsor: Spatz FGIA, Inc · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A prospective, Multicenter open-label post approval trial for 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. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.

Detailed description

The purpose of the study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling. Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks. Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects will follow a 1000-1200 kcal/day-deficit diet during their participation in the study. At 18 weeks ±4 weeks, subjects will be evaluated, and those that meet the criteria will undergo an adjustment procedure wherein the balloon volume will be increased to achieve extra weight loss. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. At the end of the 32-week treatment period, all subjects who lost at least 5% Total Body Weight Loss (TBWL) prior to device removal will be followed for an additional 6 months. In addition, patients with device- and/or procedure-related adverse events will be followed until resolution of the event

Conditions

• Obesity

Timeline

• Start date: 2021-12-03
• Primary completion: 2025-01-13
• Completion: 2025-01-13
• First posted: 2021-10-20
• Last updated: 2025-05-30

Locations

22 sites across 2 countries: United States, Puerto Rico