Obesitas Obesity
Conditions
Interventions
The medical intervention consists of the implantion of the exilis system using
a laprorascopic surgical procedure. Placement of two electrodes near the
pylorus and the remaining of the system in the
Sponsors
Medtronic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To obtain first-in-human experience with the Exilis* system, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances). These data will inform decisions about whether to pursue further clinical studies with the Exilis* system, or whether the Exilis* system or the way it is used should be modified before pursuing further clinical studies. 2. To gain an understanding of what sensations, if any, subjects feel during GES treatment, and what level and type of sensations subjects find acceptable and comfortable during chronic daily treatment. If subjects do report sensations during GES, data collection on these sensations will be used to develop sensory-based programming procedures for the Exilis* system to aid identifying the highest comfortable pulse amplitude for chronic treatment during a single brief clinic visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether GES delivered with the Exilis* system delays gastric emptying, and whether any GES-induced delay in emptying persists under prolonged chronic daily treatment. Medtronic*s preclinical research has found that GES like that delivered by the Exilis* system delay gastric emptying in rodents, canines and swine, and that a larger GES-induced delay in gastric emptying in rodents correlates with a larger GES-induced reduction in feeding. Delayed gastric emptying has been linked to early and prolonged satiation in both humans and animals , and is suspected to be part of the mechanism of action by which the Exilis *GES system may reduce food intake and body weight. Thus an objective of the study is to confirm whether GES-induced delays in gastric emptying observed in animal models can be replicated in humans. 2. To determine whether GES delivered with the Exilis *system suppresses post-meal gastric contractile activity. Medtronic*s preclinical research has included numerous measurements of gastric contractile activity in canines following the ingestion of a solid meal. These tests have repeatedly shown that GES treatments like that delivered by the Exilis* system suppress post-meal gastric contractile activity that occurs during the processing of a meal into chyme before it passes into the small intestine. This effect is at least part of the mechanism by which GES delays gastric emptying. In canines this post-meal motility suppression effect of GES has been measured using a manometric catheter placed in the gastric antrum, and observed directly via fluoroscopy following a barium-labeled test meal. In the proposed study, gastric contractile activity will be monitored noninvasively using a SmartPill gastrointestinal pressure, pH and temperature monitoring device that will be ingested with water by the subject just prior to consumption of the breakfast test meal. 3. To determine whether GES delivered with the Exilis* system reduce | — |
Countries
Netherlands
Outcome results
None listed