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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
ODC (one day capsule) type 1 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.
ODC (one day capsule) type 2 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.
Meir Medical Center
Kfar Saba, Israel
Occurrence and severity of all adverse events
Safety evaluation
Time frame: During the whole study duration (approximately 8 days)
Incidence of device-related adverse events
Safety evaluation
Time frame: During the whole study duration (approximately 8 days)
Incidence of clinically significant abnormal laboratory values as determined by the investigator
Safety evaluation
Time frame: During the whole study duration (approximately 8 days)
Excretion of the study capsules in a natural manner
Safety evaluation - confirmation of the capsule excretion from the body
Time frame: up to 3 days after the days of the capsules ingestion
Satiety levels
Changes in satiety levels resulting of the electrical stimulation
Time frame: Day #1 and #3 of the treatment period
Appetite levels
Changes in appetite levels resulting of the electrical stimulation
Time frame: Day #1 and #3 of the treatment period
Postprandial symptoms
Evaluation of postprandial symptoms during the treatment period
Time frame: Day #1, #2, #3 and #4 of the treatment period
Response to nutrient drink test
Determination of the maximum tolerable drinking volume followed by postprandial symptoms measurement
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day #3 of the screening period and and day #4 of the treatment period
Appetite-related hormone
Evaluation of appetite- related hormones levels change as a result of the stimulation applied
Time frame: Day #1 and Day #3 of the treatment period