Overweight and Obesity Clinical Trial
Official title:
A First in Human (FIH) Study to Assess the Safety and Feasibility of the Bio-electrical One Day Capsule (ODC) System (Type 1 and 2 Capsules) in Overweight and Class 1 Obese Subjects
The study represents the first effort to prospectively investigate the Melcap's bio-electrical ingestible ODC system in human. The study goal is to evaluate the safety and feasibility of GES treatment in stomach and in the small and large bowel during and following the ingestion of the bio-electrical capsule under tight and controlled conditions.
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 System Ltd. has developed an innovative ingestible capsule system device that uses GES
for the treatment of overweight and obesity. The system is intended to suppress hunger,
reduce appetite, increase satiation and promote weight reduction in overweight and class I
obese adults who have a Body Mass Index of 27 kg/m2 to 34.9 kg/m2 with no related co-morbid
conditions.
The study is a FIH prospective, open label, randomized study. It will include a 3 days
screening period and 4 days treatment session under a close supervision and follow up. Each
subject will ingest a total of 2 capsules (ODC) on the first and the third day of the study.
The total duration of subject participation including the termination visit will be eight
days.
The study will be conducted at a single medical center, Meir Hospital, Israel.
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