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Overweight and ObesityNCT03734081

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

A study testing ODC system (type 1 capsule) and ODC system (type 2 capsule) in people with Overweight and Obesity, run by Melcap Systems Ltd. at 1 site in Israel.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
ODC system (type 1 capsule) and ODC system (type 2 capsule)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteIsrael
Study dates
4 Feb 2019to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Meir Medical Center

    Kfar Saba, 4428164

Other trials in Israel

About this study

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.

Read the 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.

Being tested
ODC system (type 1 capsule), ODC system (type 2 capsule)
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT03734081
Study groupRoleWhat they receive
Gastric electrical stimulation with type 2 ODCExperimentalSafety and feasibility assessment of the ODC system (type 2) capsule during and following gastric electrical stimulation protocol.
Receives: Device: ODC system (type 2 capsule)
Electrical stimulation with type 2 ODCExperimentalSafety and feasibility assessment of the ODC system (type 2) capsule during and following small and large bowel electrical stimulation protocol.
Receives: Device: ODC system (type 2 capsule)
Electrical stimulation with type 1 ODCExperimentalSafety and feasibility assessment of the ODC system (type 1 capsule) during and following small and large electrical stimulation protocol.
Receives: Device: ODC system (type 1 capsule)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence and severity of all adverse events

    Safety evaluation

    Measured: During the whole study duration (approximately 8 days)

  2. Incidence of device-related adverse events

    Safety evaluation

    Measured: During the whole study duration (approximately 8 days)

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

    Safety evaluation

    Measured: During the whole study duration (approximately 8 days)

  4. Excretion of the study capsules in a natural manner

    Safety evaluation - confirmation of the capsule excretion from the body

    Measured: up to 3 days after the days of the capsules ingestion

Secondary outcomes (5)

  1. Satiety levels

    Changes in satiety levels resulting of the electrical stimulation

    Measured: Day #1 and #3 of the treatment period

  2. Appetite levels

    Changes in appetite levels resulting of the electrical stimulation

    Measured: Day #1 and #3 of the treatment period

  3. Postprandial symptoms

    Evaluation of postprandial symptoms during the treatment period

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

  4. Response to nutrient drink test

    Determination of the maximum tolerable drinking volume followed by postprandial symptoms measurement

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

  5. Appetite-related hormone

    Evaluation of appetite- related hormones levels change as a result of the stimulation applied

    Measured: Day #1 and Day #3 of the treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start4 Feb 2019
  3. Primary completionDec 2019 (estimated)
  4. Study completionMar 2020 (estimated)

Why it stopped: The first cohort of 6 subjects that has been enrolled is being analyzed and evaluated on all safety parameters as described in the study protocol.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03734081
Sponsor's protocol ID
CLD-012
Status last verified
Dec 2018
First submitted
4 Nov 2018
Last updated
15 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ODC system (type 1 capsule) and ODC system (type 2 capsule) in people with Overweight and Obesity, run by Melcap Systems Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence and severity of all adverse events (time frame: During the whole study duration (approximately 8 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03734081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.

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