The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.
This study is intended to provide additional data regarding the performance and safety of the abiliti system in comparison to gastric banding. The composite end-point of the study is designed to provide a direct comparison of the effectiveness of the devices for the treatment of obesity while giving consideration to the safety profile for each device and their impact on patient quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Subjects will receive implanted abiliti System.
Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.
Polyclinique de Rillieux, Clinique Lyon-Nord
Rillieux Cedex, France
RECRUITINGMIC Ev. Krankenhaus Hubertus
Berlin, Germany
Non-inferiority of the abiliti therapy compared to adjustable gastric banding
The non-inferiority of the abiliti therapy compared to adjustable gastric banding will be measured using a composite endpoint at the end of the study period. The success criteria will be the percentage of subjects in each group who meet all of the following criteria: * Achieve at least 20% excess weight loss (%EWL) from implant to end of the study period. * Experience no serious or severe adverse events related to the device or the procedure * No significant negative change in quality of life using the Impact Of Weight On Quality Of Life-Lite Questionnaire (IWQOL-Lite)
Time frame: 12 months
Percentage of Responders
Fifty (50 %) of the subject population must obtain an EWL ≥ 25%
Time frame: 12 months
Safety
* Incidence and seriousness of all adverse events. * Incidence of device or procedure-related adverse events * Frequency of clinically significant abnormal laboratory values as determined by the Investigator;
Time frame: 12 months
Safety
Frequency of device and procedure-related adverse events
Time frame: 6 and 12 months
Quality of Life
Change in the quality of life using the IWQOL-Lite questionnaire
Time frame: 6 and 12 months
Eating Behavior
Change in the eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ).
Time frame: 6 and 12 months
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SRH Wald-Klinikum Gera
Gera, Germany
RECRUITINGWolfart Klinik
Gräfelfing, Germany
ACTIVE_NOT_RECRUITINGUniversitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGStadtkrankenhaus Schwabach
Schwabach, Germany
RECRUITINGAzienda Ospedaliera- University
Pisa, Italy
NOT_YET_RECRUITINGClinica San Luca Torino
Turin, Italy
NOT_YET_RECRUITINGVicenza Regional Hospital
Vicenza, Italy
NOT_YET_RECRUITINGComplutense University of Madrid Hospital Clinico "San Carlos"
Madrid, Spain
NOT_YET_RECRUITING...and 5 more locations
Co-morbid Conditions
Evaluation of the changes in blood pressure, lipid panel, HbA1c
Time frame: 6 and 12 months