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A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon

NCT04800835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-11-28

No results posted yet for this study

Summary

The purpose of this study is to compare a 12-month adjustable balloon over a 6-month non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months.

Conditions

  • Overweight and Obesity

Interventions

DEVICE

Gastric Balloon

implantation of two types of gastric balloons. Spatz3 Adjustable balloon will be implanted for 12 months and 6-month non adjustable balloon will be implanted for 6 months

Sponsors & Collaborators

  • Spatz FGIA, Inc

    lead OTHER

Principal Investigators

  • Evžen Machytka, MD, PhD · Asclepiades - Interna a Gastroenterologie, s.r.o.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2022-07-10
Completion
2022-07-10

Countries

  • Czechia

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 NCT04800835 on ClinicalTrials.gov