The main objective of this study is to evaluate the LGL102 implant safety in obese to morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight changes will be also evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Subjects will receive implanted OMS102 System.
Wolfart Klinik
Gräfelfing, Germany
Stadtkrankenhaus Schwabach
Schwabach, Germany
Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin
Würzburg, Germany
Transgastric sensor site healing
Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant.
Time frame: 3 months
Excess weight loss
Percentage of excess body weight loss (%EWL) compared to baseline.
Time frame: 3, 6, and 12 months
Safety Evaluation
Occurrence and severity of all adverse events
Time frame: 3, 6, and 12 months
Quality of Life
Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire
Time frame: 3, 6 and 12 months
Eating Behavior
Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ)
Time frame: 3, 6 and 12 months
Comorbid Conditions
Any reduction of blood pressure and oral diabetes medications
Time frame: 3, 6 and 12 months
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