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

NCT03734081 | Suspended

• 1 other identifier: CLD-012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (4)

• Occurrence and severity of all adverse events

  Safety evaluation

  During the whole study duration (approximately 8 days)

• Incidence of device-related adverse events

  Safety evaluation

  During the whole study duration (approximately 8 days)

• Incidence of clinically significant abnormal laboratory values as determined by the investigator

  Safety evaluation

  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

  up to 3 days after the days of the capsules ingestion

Secondary Outcomes (5)

• Satiety levels

  Day #1 and #3 of the treatment period

• Appetite levels

  Day #1 and #3 of the treatment period

• Postprandial symptoms

  Day #1, #2, #3 and #4 of the treatment period

• Response to nutrient drink test

  Day #3 of the screening period and and day #4 of the treatment period

• Appetite-related hormone

  Day #1 and Day #3 of the treatment period

Study Arms (3)

Gastric electrical stimulation with type 2 ODC

EXPERIMENTAL

Safety and feasibility assessment of the ODC system (type 2) capsule during and following gastric electrical stimulation protocol.

Device: ODC system (type 2 capsule)

Electrical stimulation with type 2 ODC

EXPERIMENTAL

Safety and feasibility assessment of the ODC system (type 2) capsule during and following small and large bowel electrical stimulation protocol.

Device: ODC system (type 2 capsule)

Electrical stimulation with type 1 ODC

EXPERIMENTAL

Safety and feasibility assessment of the ODC system (type 1 capsule) during and following small and large electrical stimulation protocol.

Device: ODC system (type 1 capsule)

Interventions

ODC system (type 1 capsule) DEVICE

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.

Electrical stimulation with type 1 ODC

ODC system (type 2 capsule) DEVICE

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.

Electrical stimulation with type 2 ODC; Gastric electrical stimulation with type 2 ODC

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 21-65 years old at time of screening
• Body mass Index (BMI) \>= 27 and \<35
• 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
• Female subjects at reproductive age that are tested negative for pregnancy
• 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
• No significant weight loss (\<5%) within four months prior to enrollment (by self -report)
• No recorded or treated psychological disorder(s) for at least six months prior to enrollment (by self report)
• Not taking anti-depressant medication, for at least six months prior to enrollment.
• Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of he trial.
• Personally motivated and willing to comply with all the requirements of the clinical trial
• Able to understand, read and voluntary sign the inform consent form
• Agree and able to sign the consent form for the Pillcam(R) patency capsule test as is in use at Meir MC.

You may not qualify if:

• History o abdominal or gastrointestinal surgery (appendectomy, hernia repair, gynecological surgeries and cholecystectomy more than a year ago are allowed)
• Prior bariatric surgery
• Implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
• Unwillingness to stop medication altering gastric pH and/or affecting GI motility during the entire study duration.
• Known diagnosed psychiatric conditions that may impair subject's ability to comply with the study procedures (by self-report)
• Use of anti-psychotic medications
• Diagnosed with an eating disorder including bulimia and binge eating
• Swallowing difficulties
• Significant active or unstable acute or chronic illnesses/ diseases including gastrointestinal, systemic (non-gastrointestinal) and psychiatric conditions
• Use of another investigation device or agent in the 30 days prior to enrollment
• Women who are pregnant, lactating or anticipate to becoming pregnant within the study duration
• Planned or contemplated use of Magnetic Resonance Imaging (MRI) or any (e.g. oncologic) radiation during the course of the trial.
• Have a family member who is currently participating in this clinical trial
• Any other conditions that, in the opinion of the investigator, would make the subject unsuitable for the study

Sponsors & Collaborators

• Melcap Systems Ltd.: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Timna Naftali, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 7, 2018
• Study Start: February 4, 2019
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 15, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)