Early Feasibility Clinical Study of Gastric Electrical Stimulation (GES) for the Treatment of Obesity using the Exilis* System

Completed

Conditions: Obesitas
Obesity

Registration Number: NL-OMON39780

Lead Sponsor: Medtronic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Subject is 21-64 years of age inclusive at time of screening;
2. Subject is willing to sign and date an informed consent and a data privacy authorization for their Participation;
3. Subject has a BMI of 40-45 kg/m 2 or 35-39.9 kg/m2 with at least one weight-related comorbidity diagnosed prior to screening; (e.g. , obstructive sleep apnea, nonalcoholic steatohepatitis, hypertension, dyslipidemia, gastroesophageal reflux disease, asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis);
4. If subject is diagnosed with diabetes mellitus, must be Type 2 diabetes diagnosed within the last 7 years, currently treated with diet, exercise and /or oral agents only, and with a HbA1c of *8% without significant complications due to their diabetes in the judgment of the principal investigator;
5. Subject must be an acceptable candidate for laparoscopic implant under general anesthesia of the Exilis* system in the opinion a qualified surgeon performing the implant and can anatomically accommodate all implanted hardware which includes the ability to palpate the rib cage at the intended ICC implant location;
6. Subject reports failure at prior weight loss attempts using non-surgical approaches;
7. Subject reports their weight as being within 5% of their current body weight for at least one year;
8. Subject must, if female, be at least two years post-menopausal (defined as two years without menses), or surgically sterile (must be documented), or must agree to the use of effective contraception (devices, oral or implanted) for the duration they are enrolled in the study;
9. Subject must, if female, be non-lactating, and if of child-bearing potential, have a negative serum pregnancy test result prior to implant;
10. Subject must speak and understand English or Dutch with sufficient proficiency to read, comprehend, and sign the informed consent document and privacy statement, and to communicate with study staff;
11. Subject must have regular access to the internet running one of the following browsers: Internet Explorer 8+, Firefox 3+, Safari 4+, or Google chrome;
12. Subject reports having regular sleeping hours that do not frequently vary due to night shift worker regular long distance travel across four or more time zones;
13. Subject is willing to comply with daily recharging of device up to 90 minutes daily;
14. Subject is willing to fast overnight with no food, water only, for up to 12 hours;
15. Subject is willing to swallow a large rounded pill capsule, approximately 1.3 cm in diameter
16. Subject is willing to complete all scheduled study visits and procedures as defined in the Informed Consent;

Exclusion Criteria

1. Subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the Investigator, would limit study participation;
2. Subject has presence of untreated or inadequately treated DMS-IV AXIS I (or greater) disorder and/or significant problematic eating behaviors that could interfere with long-term goals; unrealistic expectations or surgical results; might lack social support, understanding of surgery or have ineffective coping mechanism, upon completion of psychological analysis.
3. Subject has evidence of clinically significant ECG abnormalities, in the opinion of the Investigator at the Screening Visit;
4. Subject is currently taking, or has taken in the past 3 months, any prescription or over-the- counter medications that, in the Investigator's opinion could interfere with the subject*s suitability for participation in the study, including in particular any medications taken for the purpose of weight loss or that have been shown to affect GI motility;
5. Subject has been diagnosed with an eating disorder within the past five years;
6. Subject had prior GI surgery (e.g. bariatric surgery, fundoplication, gastric resection or major upper abdominal surgery);
7. Subject has a history of inflammatory disease (e.g. Crohn*s disease or ulcerative colitis) of the GI tract;
8. Subject has a history of functional and/or motility disease (e.g., gastroparesis) of the GI tract;
9. Subject has a history of pulmonary embolism or blood coagulation disorders;
10. Subject has a history of gastric bezoar, diverticulitis, disorders of swallowing, dysphagia to food or pills, suspected strictures, fistulas, or physiological obstruction in the GI tract;
11. Subject has an allergy or sensitivity to wheat, egg, soy, milk, tree nuts, or orange juice, all of which my be contained in the test meals consumed for the study gastric emptying or solid meal satiety tests;
12. Subject has a known genetic cause of obesity (e.g., Prader-Willi Syndrome);
13. Subject currently has active implantable medical devices or wears external stimulation and/or drug delivery medical devices;
14. Subject reports anticipating undergoing an MRI examination during the study duration; or subject reports anticipating undergoing diathermy (shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) during the study duration;
15. Subject is currently participating in any investigational drug, device or biologic study; and
16. Subject has a history of heart disease (e.g. angina, history of myocardial infarction, previously documented arrhythmia) that may increase the risk of sudden cardiac death, in the opinion of the Investigator.