This study is a prospective single-arm, multicenter study to evaluate the safety and effectiveness of the TOGA® Procedure for the treatment of morbid obesity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity
ULB (Universite Libre de Bruxelles) - Erasme Hospital
Brussels, Belgium
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Rome, Italy
Percent excess weight loss (%EWL)
Time frame: up to 60 months
Adverse events, including serious adverse events, will be recorded to determine safety
Time frame: up to 60 months
Improvement in Co-morbidities
Time frame: up to 60 months
Improvements in other Obesity Measures and Change in Quality Of Life Measures
Time frame: up to 60 months
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