Colo-rectal CancerNCT03989180
Development Study of Check-Cap Imaging System in Healthy Volunteers
An observational study of Colo-rectal Cancer, run by Check-Cap Ltd. at 1 site in Israel.
Trial summary
To evaluate the performance of Check-Cap Imaging System in healthy volunteers in a variety of operating scenarios. The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a capsule and the capsules do not have any radioactive source Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- C-Scan System
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jan 2016to 6 Dec 2020
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population in this study will be composed of male and female subjects older than 25 and younger than 75 years old that volunteer for the experiment and qualify with the inclusion / exclusion criteria A total of Thirty (30) subjects will be enrolled in this study. All study participants will fit the body dimensions listed below (inclusion criteria) Efforts will be made to maintain balanced numbers between men and women and even distribution of ages.
Who may be able to join
- Male or female between 20 and 75 years of age
- Subjects who are generally healthy
- Subjects who fit the following body dimensions:
- Height: 150-200 cm
- Weight : 50-140 Kg
- BMI: 20-35
Show all 9Show fewer
- Subjects who are ready to follow the various physical activities such as: walking, running, sitting, driving, bending etc.
- Subjects who are free to spend up to 4 days carrying the back recorder system.
- Sign informed consent Form.
Who cannot join
- Subjects with cancer or other life threatening diseases or conditions
- Pregnant women
- Subjects with cardiac pacemaker or any other implanted or external portable medical device (i.e. infusion pumps)
- Bed-ridden or sedentary subjects
- Subjects who suffer significant movement limitations (who cannot follow the typical activities of walking, driving, bending, sitting etc.)
- Morbid Obesity (BMI > 35)
- Subjects under custodial care
- Participation in current clinical study or clinical study within 30 days prior to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the performance of Check-Cap Imaging System in healthy volunteers in a variety of operating scenarios.
The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a capsule and the capsules do not have any radioactive source
Read the detailed description
- st visit - Subjects will be referred to the study by an advertisement in the local media
- The subjects will receive a preliminary explanation about the study procedure and required activities. If the subjects agree to participate in the study will be asked to sign the ICF
- Subjects will be screened for eligibility according to the inclusion/exclusion criteria.
- The date for their participation will be coordinated at their convenience
- nd visit - Subject will arrive to the company R\&D lab and will receive detailed introduction about the procedure and instruction for the daily activities. (The total duration of Check-Cap Imaging System study for each subject is up to 4 days).
- Subjects will receive detailed instructions (verbally and written) about the normal operation of the C-Scan System and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary.
- The C-Scan Track will be attached to their lower back to test its functionality and the capsule will be attached to their abdomen to test the effect on data transmission during daily activities.
- The interference of the back recorder with the cloths (belt, bra etc.) will be monitored for any discomfort.
- Subjects will be asked to complete a personal diary which documents the time and duration of significant activities during the procedure such as meal times, sleeping times, physical activities etc.
- Some subjects will be instructed to be stationary during short sessions (10-20-30 min) and may read, watch TV or use the Internet. The localization data will be collected on a dedicated portable computer via these detectors.
- The monitoring routine for each subject will include but not limited to the following parameters:
- The well-being of the subject, and his/her daily routine: work, meals, driving, public transportation, mild sport, shower, sleep, other activities
- Inquiries about any discomfort caused by the recorder
- Inquiries about any discomfort or skin irritation caused by the patches.
- Inquiries about the function of the recorder as indicated by the recorder visual \& indicators
- Ease of operation of the push buttons positioned on the recorder (reaching to the lower back with w/out direct vision (mirror)
- Responding to auditory and visual indicators position on the recorder
- Some subjects will be asked to continue carrying the back recorder system for few more days in order to evaluate the effects of the system on their daily activities.
- A subjective questionnaire will be filled by the subjects following each phase of the evaluation in order to solicit immediate feedback regarding any discomfort or complaint During the current development study the plan is to simulate some of these scenarios and evaluate the functionality of the back-recorder and communication with the capsule
- Subjects will continue their daily routine: work, sleep, shower, driving in car or public transportation, sit, stand, walk.
- Subjects should refrain from active sport such as jogging, physical exercise in the gym, swimming, sauna, any ball-games, skiing etc.
- Subjects should refrain from Flights, boat trips or long train travels during the monitoring procedure
- Subjects should try and stay away from areas with high electromagnetic fields such as: High voltage elect. Poles, transformation station, radio and TV transmitter station etc.
- Subjects should not be examined by CT or MRI (unless it is an emergency)
- Subjects who are working in an area with high electromagnetic field should not be examined by the capsule
- Conditions
- Colo-rectal Cancer
- Being tested
- C-Scan System
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Scan SystemDevice
- Subjects will receive detailed instructions (verbally and written) about the normal operation of the recorder and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary (attached)
- The recorder will be secured to their lower back to test its functionality
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the C-Scan system in terms of communication between the C-Scan Capsule and the System Track in different locations, positions and configurations.
The C-Scan System performance will be tested in different versions, configurations and locations. The C-Scan Cap with no radioactive source will be placed on the subject's abdomen and the C-Scan Track will be placed on the subject's back in different locations. The subject will be ask to continue his/her rutine daily activities such as: sleeping, driving a car, watching TV etc for a few days.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start6 Jan 2016
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boaz Shpigelman, Study director, COO, VP R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989180
- Sponsor's protocol ID
- CL-SY-01-0092
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2019
- Last updated
- 17 Feb 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 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Study of Check-Cap Imaging System in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03989180
- Acronym / sponsor ID
- CL-SY-01-0092
- Conditions
- Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 18 Jun 2019 (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 evaluate the performance of Check-Cap Imaging System in healthy volunteers in a variety of operating scenarios.
The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a capsule and the capsules do not have any radioactive source
Detailed description
- st visit - Subjects will be referred to the study by an advertisement in the local media
- The subjects will receive a preliminary explanation about the study procedure and required activities. If the subjects agree to participate in the study will be asked to sign the ICF
- Subjects will be screened for eligibility according to the inclusion/exclusion criteria.
- The date for their participation will be coordinated at their convenience
- nd visit - Subject will arrive to the company R\&D lab and will receive detailed introduction about the procedure and instruction for the daily activities. (The total duration of Check-Cap Imaging System study for each subject is up to 4 days).
- Subjects will receive detailed instructions (verbally and written) about the normal operation of the C-Scan System and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary.
- The C-Scan Track will be attached to their lower back to test its functionality and the capsule will be attached to their abdomen to test the effect on data transmission during daily activities.
- The interference of the back recorder with the cloths (belt, bra etc.) will be monitored for any discomfort.
- Subjects will be asked to complete a personal diary which documents the time and duration of significant activities during the procedure such as meal times, sleeping times, physical activities etc.
- Some subjects will be instructed to be stationary during short sessions (10-20-30 min) and may read, watch TV or use the Internet. The localization data will be collected on a dedicated portable computer via these detectors.
- The monitoring routine for each subject will include but not limited to the following parameters:
- The well-being of the subject, and his/her daily routine: work, meals, driving, public transportation, mild sport, shower, sleep, other activities
- Inquiries about any discomfort caused by the recorder
- Inquiries about any discomfort or skin irritation caused by the patches.
- Inquiries about the function of the recorder as indicated by the recorder visual \& indicators
- Ease of operation of the push buttons positioned on the recorder (reaching to the lower back with w/out direct vision (mirror)
- Responding to auditory and visual indicators position on the recorder
- Some subjects will be asked to continue carrying the back recorder system for few more days in order to evaluate the effects of the system on their daily activities.
- A subjective questionnaire will be filled by the subjects following each phase of the evaluation in order to solicit immediate feedback regarding any discomfort or complaint During the current development study the plan is to simulate some of these scenarios and evaluate the functionality of the back-recorder and communication with the capsule
- Subjects will continue their daily routine: work, sleep, shower, driving in car or public transportation, sit, stand, walk.
- Subjects should refrain from active sport such as jogging, physical exercise in the gym, swimming, sauna, any ball-games, skiing etc.
- Subjects should refrain from Flights, boat trips or long train travels during the monitoring procedure
- Subjects should try and stay away from areas with high electromagnetic fields such as: High voltage elect. Poles, transformation station, radio and TV transmitter station etc.
- Subjects should not be examined by CT or MRI (unless it is an emergency)
- Subjects who are working in an area with high electromagnetic field should not be examined by the capsule
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population in this study will be composed of male and female subjects older than 25 and younger than 75 years old that volunteer for the experiment and qualify with the inclusion / exclusion criteria A total of Thirty (30) subjects will be enrolled in this study. All study participants will fit the body dimensions listed below (inclusion criteria) Efforts will be made to maintain balanced numbers between men and women and even distribution of ages.
Key inclusion criteria (9 listed)
- Male or female between 20 and 75 years of age
- Subjects who are generally healthy
- Subjects who fit the following body dimensions:
- Subjects who are ready to follow the various physical activities such as: walking, running, sitting, driving, bending etc.
- Subjects who are free to spend up to 4 days carrying the back recorder system.
Key exclusion criteria (8 listed)
- Subjects with cancer or other life threatening diseases or conditions
- Pregnant women
- Subjects with cardiac pacemaker or any other implanted or external portable medical device (i.e. infusion pumps)
- Bed-ridden or sedentary subjects
- Subjects who suffer significant movement limitations (who cannot follow the typical activities of walking, driving, bending, sitting etc.)
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 |
|---|---|---|
| C-Scan System* Subjects will receive detailed instructions (verbally and written) about the normal operation of the recorder and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary (attached) * The recorder will be secured to their lower back to test its functionality | Device | – |
Primary outcome
Performance of the C-Scan system in terms of communication between the C-Scan Capsule and the System Track in different locations, positions and configurations.
Time frame: 36 months
The C-Scan System performance will be tested in different versions, configurations and locations. The C-Scan Cap with no radioactive source will be placed on the subject's abdomen and the C-Scan Track will be placed on the subject's back in different locations. The subject will be ask to continue his/her rutine daily activities such as: sleeping, driving a car, watching TV etc for a few days.
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 17 Feb 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
COO, VP R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 inclusion and 8 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 17 Feb 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?
Performance of the C-Scan system in terms of communication between the C-Scan Capsule and the System Track in different locations, positions and configurations. (time frame: 36 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 17 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.