A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
NCT06373666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-15
Summary
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Conditions
- Overweight and Obesity
Interventions
- DEVICE
-
Spatz4 Adjustable Balloon System
Implantation of Spatz4 Adjustable Balloon system for weight loss treatment for Overweight and Obese patients and Adjustment of the balloon volume at week 16
Sponsors & Collaborators
-
Spatz FGIA, Inc
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-09
- Primary Completion
- 2026-02-02
- Completion
- 2026-02-02
Countries
- Czechia
Study Locations
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