CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 227 enrolled
Drug / intervention
Spatz3 AIGBdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03473938
NCT03473938N/ACompleted
CompareCT.gov

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

University Hospital Ostrava·observational·Posted Mar 22, 2018·Updated Mar 22, 2018

In Brief

An observational study evaluating Spatz3 AIGB for Obesity. Completed, enrolled 227 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesCzechia, Israel, Spain
CollaboratorsClínica Opcíon Médica Barcelona, Optimal Clinic Tel Aviv, University of Ostrava

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 22, 2018
Enrollment StartMay 1, 2015
Primary CompletionDec 31, 2015
Study CompletionJan 31, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.3 years ago

Interventions

Spatz3 AIGBdevice

Implantation of Spatz3 AIGB balloon.