Abiliti™ Treatment in Obese Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study

Conditions
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Obesity, Morbid Obesity

Intervention / Treatment
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* Device: abiliti system implant
* Device: Laparoscopic adjustable gastric band (Allergan Lap Band)


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 40 to 55 or 35 to 39 with an obesity related comorbid condition 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. Cirrhosis, chronic pancreatitis History of intestinal obstruction or adhesive peritonitis Any history of peptic ulcer disease within 5 years prior to enrollment 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. Chronic use of aspirin and/or non steroidal anti-inflammatory medications and unwillingness to discontinue use Cardiac history that physician feels should exclude the patient from the study. Concurrent use of weight loss medications. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: abiliti Group<br>Subjects will receive implanted abiliti System. The device will be activated to deliver therapy at implant. Gastric stimulation performance testing, therapy adjustment and dietary/exercise counseling will be conducted at each visit. | Device: abiliti system implant<br>* Subjects will receive implanted abiliti System.<br>* Other names: abiliti;|
| Active Comparator: Gastric Band Group<br>Subjects will receive an implanted laparoscopic adjustable gastric band. The subjects will have their band adjusted following the standard of care. Dietary/exercise counseling will be conducted at each visit. | Device: Laparoscopic adjustable gastric band (Allergan Lap Band)<br>* Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.<br>* Other names: gastric band;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 
| Percentage of Responders | Fifty (50 %) of the subject population must obtain an EWL ≥ 25% | 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; | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Frequency of device and procedure-related adverse events | 6 and 12 months | 
| Quality of Life | Change in the quality of life using the IWQOL-Lite questionnaire | 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). | 6 and 12 months | 
| Co-morbid Conditions | Evaluation of the changes in blood pressure, lipid panel, HbA1c | 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