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Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons

NCT03473938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 227

Last updated 2018-03-22

No results posted yet for this study

Summary

Intragastric balloon degree of efficacy and duration of effect can be variable and unpredictable. The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing effect. The aim of the study was to determine the utility/efficacy and responder rate with the Spatz3 AIGB.

Conditions

Interventions

DEVICE

Spatz3 AIGB

Implantation of Spatz3 AIGB balloon.

Sponsors & Collaborators

  • Clínica Opcíon Médica Barcelona

    collaborator UNKNOWN

  • Optimal Clinic Tel Aviv

    collaborator UNKNOWN

  • University of Ostrava

    collaborator OTHER

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Evžen Machytka, MD,PhD · University Hospital Ostrava

Eligibility

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

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Czechia
  • Israel
  • Spain

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 NCT03473938 on ClinicalTrials.gov