Status:
COMPLETED
Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
Lead Sponsor:
University Hospital Ostrava
Collaborating Sponsors:
Clínica Opcíon Médica Barcelona
Optimal Clinic Tel Aviv
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Brief 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, decre...
Detailed Description
The results of the Spatz adjustable balloon system have been reported in four studies with weight losses of 24.4 kg (48.8% excess weight loss - EWL), 21.6 kg (45.7% EWL),17.2 kg (42.9% EWL) and 16.3 k...
Eligibility Criteria
Inclusion
- temporary weight loss treatment in a patient with body mass index (BMI) in the range of bariatric surgery (\>35) who refuse surgery or are at high risk for surgery
- temporary weight loss treatment for a patient without indications for surgery (BMI \> 29)
Exclusion
- \- none
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2016
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT03473938
Start Date
May 1 2015
End Date
January 31 2016
Last Update
March 22 2018
Active Locations (4)
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1
University of Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 701 03
2
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52
3
Optimal Clinic
Tel Aviv, Israel
4
Clínica Opcíon Médica
Barcelona, Spain