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

NCT05007964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Overweight and Obesity

Interventions

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.

Sponsors & Collaborators

  • Spatz FGIA, Inc

    lead OTHER

Principal Investigators

  • MANOEL GALVAO NETO, MD · Fundação do ABC - FMABC

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
2022-06-14
Primary Completion
2023-08-29
Completion
2023-08-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05007964 on ClinicalTrials.gov