Colo-rectal CancerNCT03785665
Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy
A study testing MDI in people with Colo-rectal Cancer, run by Check-Cap Ltd. at 1 site in Israel.
Trial summary
To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home Monitoring, Prospective Study. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- MDI
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jun 2019to 11 Jan 2022
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 40 and 80 years of age
- Subjects which are generally healthy
- Subjects who were examined by colonoscopy during the previous 5 years period and can provide a copy of the report
- Subjects who are ready to undergo the monitoring routine and commit to at least two experiments
- Signed informed consent.
Who cannot join
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subject with known history of dysphagia or other swallowing disorders
- Subject with known history of Gastrointestinal disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory bowel disease (IBD), Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
- Subject with known delayed gastric emptying
- Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
Show all 14Show fewer
- Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or Nonsteroidal anti-inflammatory drugs (NSAID) enteropathy, as determined by physician discretion
- Subjects with known sensitivity to iodine, or with kidney failure
- Subjects with morbid obesity (Body Mass Index > 35)
- Subjects with belly / girth circumference > 125 cm
- Subject with any known condition which precludes compliance with study and/or device instructions
- Subject with known condition of drug abuse and/or alcoholism
- Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
- Concurrent participation in another clinical trial using any investigational drug or device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Monitor the Whole Gut Transit Time and Repeatability of the Motility of MD1 Capsules in the Colon of Subjects With Known Polyps and in Healthy Subjects
To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per person, (1 capsule at a time) The primary objective of the study is to monitor the variability of the motility of the MD1 capsules in the Gastrointestinal tract of human subjects with and without polyps in previous Colonoscopy.
Read the detailed description
The subject population in this study will be composed of male and female subjects older than 40 and younger than 80 years old who volunteer for the experiment and qualify with the inclusion / exclusion criteria A total of one hundred (100) subjects will be enrolled in this study. All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages.
The study will be conducted by phases:
A 15-20 Men with polyps in previous Colonoscopy (2-3 repeated ingestions) B. 10-20 Men With no polyps in previous Colonoscopy (1-2 repeated ingestions) C. 15-20 Women with polyps in previous Colonoscopy (2-3 repeated ingestions) D. 10-20 Women With no polyps in previous Colonoscopy (1-2 repeated ingestions) E Same as A-D with the use of prokinetic drugs F. Same as A-D with different type of capsules (lower weight and/or rounded caps on both sides).
The total duration of the study for each subject is two-four weeks. Each subject will ingest 2-5 capsules, one at a time, with at least 1 week apart between repeated ingestion
- st Visit (phone interview) - Each subject will receive a comprehensive explanation regarding the study nature. During this process, and per ethical committee approval, subjects may be asked several questions (over the phone) regarding their medical background for preliminary assessment of eligibility.
- nd Visit - Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria.
Consent to participate in this study must be given in writing. The signed informed consent will remain in subject's file. A signed copy will be given to the subject.
Subject will ingest the capsule (in the presence of a medical professional).
Post ingestion, the subject will receive detailed instructions about the daily routine and activities and then will be discharged home with written instructions on the procedure (IFU - Instructions for use). The subject should avoid intensive physical exercise during the procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings (within 2 hours of driving from the clinic), and may continue daily activities such mobile/computer/TV (Television) use, shower, sleep or eat.
Details on allowed and restricted activities are listed in the Information For use which is included in the Kit).
All subjects will be provided with a contact card with study details and site contact information (24/7).
Discharged home
- Conditions
- Colo-rectal Cancer
- Being tested
- MDI
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDIDevice
Also called Capsule MD1 (Motility dummy 1)
Capsule MD1 (Motility dummy 1)
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages Receives: Device: MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy.
All participating subjects will be consented for multiple measurements. In selected subjects the experiment will be repeated with same type MD1 capsule but w/out the drug, to compare the effect of the drug on the motility and the instantaneous speed during contractions. These subjects will be selected according to their results in the first round, ease of adjustment to the monitoring routine, retrieval of the excreted capsules and lack of any side effects or complains.
The repeated procedure will be at least 1 week apart and will be approved by the investigator only after positive identification of the excretion of the first capsule. Naturally, there is no need to repeat the colonoscopy procedure The repeated tests will be conducted according to the same protocol. There are no additional safety issues in the re-ingestions tests since the 1st capsule has to be excreted and retrieved few days before the repeated experiment starts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start15 Jun 2019
- Primary completion1 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-Center, Open, Home Monitoring, Prospective Study
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boaz Shpigelman, Study director, VP R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785665
- Sponsor's protocol ID
- CL-MD1-01-0097
- Status last verified
- Jan 2022
- First submitted
- 28 Nov 2018
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Monitor the Whole Gut Transit Time and Repeatability of the Motility of MD1 Capsules in the Colon of Subjects With Known Polyps and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03785665
- Acronym / sponsor ID
- CL-MD1-01-0097
- Conditions
- Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per person, (1 capsule at a time) The primary objective of the study is to monitor the variability of the motility of the MD1 capsules in the Gastrointestinal tract of human subjects with and without polyps in previous Colonoscopy.
Detailed description
The subject population in this study will be composed of male and female subjects older than 40 and younger than 80 years old who volunteer for the experiment and qualify with the inclusion / exclusion criteria A total of one hundred (100) subjects will be enrolled in this study. All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages.
The study will be conducted by phases:
A 15-20 Men with polyps in previous Colonoscopy (2-3 repeated ingestions) B. 10-20 Men With no polyps in previous Colonoscopy (1-2 repeated ingestions) C. 15-20 Women with polyps in previous Colonoscopy (2-3 repeated ingestions) D. 10-20 Women With no polyps in previous Colonoscopy (1-2 repeated ingestions) E Same as A-D with the use of prokinetic drugs F. Same as A-D with different type of capsules (lower weight and/or rounded caps on both sides).
The total duration of the study for each subject is two-four weeks. Each subject will ingest 2-5 capsules, one at a time, with at least 1 week apart between repeated ingestion
- st Visit (phone interview) - Each subject will receive a comprehensive explanation regarding the study nature. During this process, and per ethical committee approval, subjects may be asked several questions (over the phone) regarding their medical background for preliminary assessment of eligibility.
- nd Visit - Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria.
Consent to participate in this study must be given in writing. The signed informed consent will remain in subject's file. A signed copy will be given to the subject.
Subject will ingest the capsule (in the presence of a medical professional).
Post ingestion, the subject will receive detailed instructions about the daily routine and activities and then will be discharged home with written instructions on the procedure (IFU - Instructions for use). The subject should avoid intensive physical exercise during the procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings (within 2 hours of driving from the clinic), and may continue daily activities such mobile/computer/TV (Television) use, shower, sleep or eat.
Details on allowed and restricted activities are listed in the Information For use which is included in the Kit).
All subjects will be provided with a contact card with study details and site contact information (24/7).
Discharged home
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-Center, Open, Home Monitoring, Prospective Study
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: MDIAll study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female between 40 and 80 years of age
- Subjects which are generally healthy
- Subjects who were examined by colonoscopy during the previous 5 years period and can provide a copy of the report
- Subjects who are ready to undergo the monitoring routine and commit to at least two experiments
- Signed informed consent.
Key exclusion criteria (14 listed)
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subject with known history of dysphagia or other swallowing disorders
- Subject with known history of Gastrointestinal disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory bowel disease (IBD), Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
- Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
- Subject with known delayed gastric emptying
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDIAlso: Capsule MD1 (Motility dummy 1)Capsule MD1 (Motility dummy 1) | Device | Participants |
Primary outcome
Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy.
Time frame: 12 months
All participating subjects will be consented for multiple measurements. In selected subjects the experiment will be repeated with same type MD1 capsule but w/out the drug, to compare the effect of the drug on the motility and the instantaneous speed during contractions. These subjects will be selected according to their results in the first round, ease of adjustment to the monitoring routine, retrieval of the excreted capsules and lack of any side effects or complains. The repeated procedure will be at least 1 week apart and will be approved by the investigator only after positive identification of the excretion of the first capsule. Naturally, there is no need to repeat the colonoscopy procedure The repeated tests will be conducted according to the same protocol. There are no additional safety issues in the re-ingestions tests since the 1st capsule has to be excreted and retrieved few days before the repeated experiment starts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boaz Shpigelman study director
VP R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDI in people with Colo-rectal Cancer, run by Check-Cap 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 5 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: finished, as of the sponsor's last update on 19 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.