Safety and Feasibility Assessment of the Bio-electrical One Day Capsule System in Overweight and Class I Obese Participants

Launched by MELCAP SYSTEMS LTD. · Nov 6, 2018

Keywords

ClinConnect Summary

The problem of obesity in the adult population requires the exploration and development of new, safe and effective therapies to combat increasing growth. A novel Implantable Gastric Electrical Stimulation (GES), MEASTRO(R) Rechargeable System, has been recently approved by the American Food and Drug Administration (FDA) for use in weight reduction in patients aged 18 years through adulthood who have a Body Mass Index (BMI) of 40 to 45 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one supervised management program within the past 5 years.

Melcap Syste...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age of 21-65 years old at time of screening
• • 2. Body mass Index (BMI) \>= 27 and \<35
• • 3. The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 4 months prior to enrollment
• • 4. Female subjects at reproductive age that are tested negative for pregnancy
• • 5. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods during the whole study duration
• • 6. No significant weight loss (\<5%) within four months prior to enrollment (by self -report)
• • 7. No recorded or treated psychological disorder(s) for at least six months prior to enrollment (by self report)
• • 8. Not taking anti-depressant medication, for at least six months prior to enrollment.
• • 9. Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of he trial.
• • 10. Personally motivated and willing to comply with all the requirements of the clinical trial
• • 11. Able to understand, read and voluntary sign the inform consent form
• • 12. Agree and able to sign the consent form for the Pillcam(R) patency capsule test as is in use at Meir MC.
• Exclusion Criteria:
• • 1. History o abdominal or gastrointestinal surgery (appendectomy, hernia repair, gynecological surgeries and cholecystectomy more than a year ago are allowed)
• • 2. Prior bariatric surgery
• • 3. Implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
• • 4. Unwillingness to stop medication altering gastric pH and/or affecting GI motility during the entire study duration.
• • 5. Known diagnosed psychiatric conditions that may impair subject's ability to comply with the study procedures (by self-report)
• • 6. Use of anti-psychotic medications
• • 7. Diagnosed with an eating disorder including bulimia and binge eating
• • 8. Swallowing difficulties
• • 9. Significant active or unstable acute or chronic illnesses/ diseases including gastrointestinal, systemic (non-gastrointestinal) and psychiatric conditions
• • 10. Use of another investigation device or agent in the 30 days prior to enrollment
• • 11. Women who are pregnant, lactating or anticipate to becoming pregnant within the study duration
• • 12. Planned or contemplated use of Magnetic Resonance Imaging (MRI) or any (e.g. oncologic) radiation during the course of the trial.
• • 13. Have a family member who is currently participating in this clinical trial
• • 14. Any other conditions that, in the opinion of the investigator, would make the subject unsuitable for the study