Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

Study Overview
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Brief Summary
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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.

Official Title
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Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study

Conditions
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Obesity, Morbid Obesity

Intervention / Treatment
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* Device: OMS102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 - 60 years old at time of screening BMI of 35 to 55 at time of screening History of obesity ≥ 5 years The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods No significant weight loss (< 5%) within four months prior to enrollment as documented in the subject's medical record. Successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment. Glycosylated Hemoglobin; HbA1c ≤ 7.0 % at Visit 2 or historic value performed no more than 3 months prior to enrollment. If taking anti-depressant medications, they must be stable for at least six months prior to enrollment Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial Able to provide voluntary informed consent Exclusion Criteria: Any prior bariatric surgery Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator) Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures Use of anti-psychotic medications Diagnosed with a eating disorder such as bulimia or binge eating Obesity due to an endocrinopathy (e.g. Cushing disease) Insulin therapy GI disease such as hiatal hernia (> 5cm), gastroparesis, esophageal motility disorders or intractable constipation. Any history of peptic ulcer disease within 5 years prior to enrollment History of Barrett's esophagus Women who are pregnant, lactating or anticipate becoming pregnant within 24 months Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study. Cardiac history that physician feels should exclude the patient from the study. Use of another investigational device or agent in the 30 days prior to enrollment A history of life-threatening disease within 5 years prior to enrollment Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OMS102|Subjects will receive implanted OMS102 System.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transgastric sensor site healing | Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss | Percentage of excess body weight loss (%EWL) compared to baseline. | 3, 6, and 12 months | 
| Safety Evaluation | Occurrence and severity of all adverse events | 3, 6, and 12 months | 
| Quality of Life | Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire | 3, 6 and 12 months | 
| Eating Behavior | Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ) | 3, 6 and 12 months | 
| Comorbid Conditions | Any reduction of blood pressure and oral diabetes medications | 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, gastric stimulation, morbid obesity