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Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

NCT05086302 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 537

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Spatz FGIA, Inc

    lead OTHER

Principal Investigators

  • Jeffrey Brooks, MD · Spatz FGIA, Inc

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2025-01-13
Completion
2025-01-13

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT05086302 on ClinicalTrials.gov