Clinical trial NCT03734081: Safety and Feasibility Assessment of the Bio-electrical One Day Capsule System in Overweight and Class I Obese Participants
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Melcap Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Occurrence and severity of all adverse events
timeFrame: During the whole study duration (approximately 8 days)
measure: Incidence of device-related adverse events
timeFrame: During the whole study duration (approximately 8 days)
measure: Incidence of clinically significant abnormal laboratory values as determined by the investigator
timeFrame: During the whole study duration (approximately 8 days)
measure: Excretion of the study capsules in a natural manner
timeFrame: up to 3 days after the days of the capsules ingestion
Secondary outcomes:
measure: Satiety levels
timeFrame: Day #1 and #3 of the treatment period
measure: Appetite levels
timeFrame: Day #1 and #3 of the treatment period
measure: Postprandial symptoms
timeFrame: Day #1, #2, #3 and #4 of the treatment period
measure: Response to nutrient drink test
timeFrame: Day #3 of the screening period and and day #4 of the treatment period
measure: Appetite-related hormone
timeFrame: Day #1 and Day #3 of the treatment period
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Timna Naftali, MD
role: PRINCIPAL_INVESTIGATOR
References: