NCT05007964

A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4)

A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Spatz FGIA, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. All subjects will follow a calorie restricted diet designed by the dietician. An up adjustment will be performed at 16 weeks (±2 weeks). The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.

Detailed description

The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. Subjects will be studied in an open label multi-center center study that will have one endpoint at 20 weeks. Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. All subjects will follow a calorie restricted diet designed by the dietician. The initial diet will be liquid and will be advanced as per the dietician's recommendations. Changes in diet will depend on subject tolerance to the balloon and specific food intolerances and will be adjusted frequently by the dietician. The initial balloon volume will be 450 to 550 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. It is estimated, based on clinical studies, that approximately 10% of subjects will be intolerant in the first month and will require a down adjustment, wherein 150 ml of fluid will be removed from the balloon. An up adjustment will be performed at 16 weeks (±2 weeks) with the addition of 200-300 ml of 0.9% normal saline. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DEVICE	Spatz4 Adjustable Balloon System	The Spatz4 Adjustable Balloon System is designed to assist weight loss by partially filling the stomach and inducing satiety. The intragastrical balloon is implanted endoscopically for up to 12 months.

Timeline

• Start date: 2022-06-14
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2021-08-17
• Last updated: 2024-12-04

Locations

1 site across 1 country: Brazil