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Spatz Adjustable Balloon for Obesity (SABO)

NCT02812160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2021-05-28

Study results available
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Summary

The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.

Conditions

Interventions

DEVICE

Spatz3 Adjustable Balloon

An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed

Sponsors & Collaborators

  • Spatz FGIA, Inc

    lead OTHER

Principal Investigators

  • Barham AbuDayyeh, MD · Mayo Clinic

  • Christopher C Thompson, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2018-10-31
Completion
2019-01-31
FDA Device
Yes

Countries

  • United States

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 NCT02812160 on ClinicalTrials.gov