Risk for Colorectal CancerCRCNCT04038736
Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
A study testing C-Scan System in people with Risk for Colorectal Cancer, run by Check-Cap Ltd. at 4 sites in Israel.
Trial summary
Up to 300 subjects will participate in this study. Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC. Each subject will undergo study assessments including a pre-screening telephone call, Procedure Visit, follow up post-ingestion via telephone calls. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk for Colorectal Cancer
- What is being tested?
- C-Scan System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesIsrael
- Study dates
- 26 Dec 2019to 27 Dec 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at the age of 40-80 years old
- Subjects who are ready to undergo the monitoring routine
- Subject provided signed informed consent
Who cannot join
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subjects with known history of dysphagia or other swallowing disorders
- Subjecta with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, 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
- Subjects with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
Show all 15Show 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 NSAID enteropathy, as determined by physician discretion
- Subject with a cardiac pacemaker or other implanted electro medical device
- Subjects with known sensitivity to iodine, or with kidney failure
- Subjects with low BMI (BMI<20) or Obese (BMI≥ 38)
- 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
4 sites in 1 country.
Israel4 sites
Haemek Medical Center
Afula
Bnai Zion Medical Center
Haifa, North, 33391
Rambam Medical Center
Haifa, North, 3525408
Tel Aviv Sorasky Medical Center
Tel Aviv
About this study
Official title: Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in Subjects at Average or High Risk for CRC
Up to 300 subjects will participate in this study. Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC.
Each subject will undergo study assessments including a pre-screening telephone call, Procedure Visit, follow up post-ingestion via telephone calls.
Read more
On the day of the procedure, before administering the C-Scan. Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria. Medical history and concomitant medications information will be collected for all subjects. Also prior surgeries or endoscopic examinations showing pathology and current or previous GI problems or symptoms will be evaluated.
Some subjects will be asked to participate in additional ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject.
Each subject's participation in the study will take up to 3 weeks (per one ingestion).
Some subjects will be asked to participate in addition ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject.
Overall study duration will be one year.
Read the detailed description
Study Population:
A total of 300 healthy subjects, Male or female, at average or high risk for CRC will be enrolled for the study.
Visit 1: C-Scan Procedure Visit This visit is performed in order to ensure that the subject continues to meet all inclusion and has no exclusion criteria, and has had adequate time to review the consent form and to ask questions. Once it has been determined that the subject meets all inclusion and has no exclusion criteria, and the subject chooses to participate in the study, the consent form will be signed and dated by all appropriate parties prior to execution of study-specific assessments. Signing the informed consent form signifies enrollment in the clinical study.
Capsule ingestion will take place at this visit. Additionally, the subject will receive detailed training session and instructions including explanation from the site study team about the device, its usage and the required documentation described below. Following subject training, the Capsule will be ingested ('C-Scan Initiation Procedure') at this visit, as described below.
C-Scan Initiation Procedure:
Subject will be connected to the C-Scan Track and system will be activated. The subject will be asked to ingest the C-Scan Capsule, in the presence of a physician with some water and water-soluble iodinated oral contrast medium indicated for radiographic examination of segments of the gastrointestinal tract and non-soluble fiber supplements.
Post ingestion, the subject will be discharged home with a Subject Instructions Packet which will include instructions on following routine daily regime (i.e., ingestion of contrast media 3 x 15ml per day and non-soluble fiber supplements X3 per day until capsule excretion) and record in a personal formatted diary the timing of specific activities such as bowel movements, daily activities and discomfort assessment via a validated scale. Also included will be Subject Satisfaction surveys that the subject should complete at the end of the procedure and return to the site upon completion.
Capsule Progress Days:
During the days in which the capsule is progressing within the subject, the subject is required to ingest contrast media (GE Omnipaque 350, FDA approved under NDA 018956) as well as non-soluble fiber supplements. The subject will be required to ingest daily dose (3 X 15 ml) of contrast media, to be consumed three times per day as well a non-soluble fiber 3x/day with normal diet.
Subjects will be required to undergo FIT procedure along with the C-Scan System procedure, per package insert instructions The subject will be provided with Laxadin (5 mg tablets) to be ingested according to the doctor recommendation, on an as needed basis. In routine procedures, subjects might be instructed to take 2 X 5 mg tablets 48-72 hours after ingestions (unless the capsule was already excreted).
Some subjects will be asked by the PI to come to the site for an abdominal X-Ray (fluoroscopy) while the capsule is still in the colon.
All subjects will be required to keep a log ('Subject's Diary') during procedure documenting general activities, contrast media intake, fibers intake, and food consumption, bowel movement, and system visual/auditory indicators.
Phone Call Follow-Up During-C-Scan Procedure :
After Capsule ingestion, the subject will be contacted by phone at least twice daily by the study team until the capsule has been excreted. The subject will be asked to provide feedback about the use of the device, excretion of the capsule, his/her general feeling or any inconvenience and will be reminded to complete the daily diary and discomfort assessment. The conversation with the subjects and their responses are tabulated and recorded in the study file.
C-Scan Procedure End:
Capsule procedure is completed upon capsule excretion or system auditory indication of 'End of Procedure'. Subjects will be asked to call the study team upon capsule excretion.
The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion. Return packaging and instructions will be provided. The subject will return with the Kit the diary, the questionnaire and all unused materials.
Follow-Up Phone Call Post-C-Scan Procedure End:
Follow up window is 1-3 days post-capsule excretion. Subject will be telephoned by study site to assess for any undesired events.
In case of doubt regarding capsule excretion, and per physician discretion, subjects may be referred to abdominal X-Ray to confirm capsule excretion.
Colonoscopy examination (optional)
- Conditions
- Risk for Colorectal Cancer
- Being tested
- C-Scan System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Scan SystemDevice
Also called C-Scan Cap, C-Scan Track
During C-Scan procedure the subject swallows the C-Scan cap. The capsule travels painlessly through the gastrointestinal tract, seeking polyps, the precursors of colorectal cancer. It is essential to increase the stool's contrast by ingesting radio-opaque material. During the passage of the capsule in the gastrointestinal tract, it transmits information to a recorder attached to the back. In order to collect data about the instantaneous localization of the capsule traveling in the colon additional sensors are embedded in the recorder on the back side. After the capsule is expelled, the data from the recorder is downloaded to an acquisition workstation. Later, the data is transferred to a processing workstation where dedicated software visualizes and analyses the data.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects at averge risk for CRC | Experimental | All subjects are healthy who didn't have any known polyps in past colonoscopy and who arw candidates for CRC screening Receives: Device: C-Scan System |
| Healthy subjects at high risk for CRC | Experimental | Subjects who had polyps in former colonoscopy, subjects who have family history of CRC or subjects who have positive stool blood test. Receives: Device: C-Scan System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Number of incidents of trial duration above 300 hours
The duration of the study procedures will be no more than 12.5 days
Measured: 12 months
Safety measurments of the C-Scan System regarding SUSAR
No Incidents of SUSAR according to CTCAE scale
Measured: 12 months
Evaluation of the performance of the C-scan System in detecting polyps≥10 mm compared to FIT results
rate of Positive and Negative Agreement of C-Scan System compared to FIT in detecting subjects with polypoid lesions ≥10 mm
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 posted31 Jul 2019
- Study start26 Dec 2019
- Primary completion27 Dec 2020
- Study completion27 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk for Colorectal 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of the performance of the C-Scan System in providing structural information on colonic polypoid lesions and masses in average risk vs. high risk subjects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomo Lewkowicz, Dsc., Study director, Check-Cap
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038736
- Sponsor's protocol ID
- CL-SY-01-0098
- Acronym
- CRC
- Status last verified
- Jan 2022
- First submitted
- 27 Jun 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in Subjects at Average or High Risk for CRC
- ClinicalTrials.gov ID
- NCT04038736
- Acronym / sponsor ID
- CRC / CL-SY-01-0098
- Conditions
- Risk for Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 31 Jul 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.
Up to 300 subjects will participate in this study. Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC.
Each subject will undergo study assessments including a pre-screening telephone call, Procedure Visit, follow up post-ingestion via telephone calls.
On the day of the procedure, before administering the C-Scan. Once informed consent is obtained, a thorough evaluation of subject's eligibility will be performed based on inclusion / exclusion criteria. Medical history and concomitant medications information will be collected for all subjects. Also prior surgeries or endoscopic examinations showing pathology and current or previous GI problems or symptoms will be evaluated.
Some subjects will be asked to participate in additional ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject.
Each subject's participation in the study will take up to 3 weeks (per one ingestion).
Some subjects will be asked to participate in addition ingestions (up to three, one at a time, at least one week intermission between the ingestions), to compare the performance of the system in different configuration on the same subject.
Overall study duration will be one year.
Detailed description
Study Population:
A total of 300 healthy subjects, Male or female, at average or high risk for CRC will be enrolled for the study.
Visit 1: C-Scan Procedure Visit This visit is performed in order to ensure that the subject continues to meet all inclusion and has no exclusion criteria, and has had adequate time to review the consent form and to ask questions. Once it has been determined that the subject meets all inclusion and has no exclusion criteria, and the subject chooses to participate in the study, the consent form will be signed and dated by all appropriate parties prior to execution of study-specific assessments. Signing the informed consent form signifies enrollment in the clinical study.
Capsule ingestion will take place at this visit. Additionally, the subject will receive detailed training session and instructions including explanation from the site study team about the device, its usage and the required documentation described below. Following subject training, the Capsule will be ingested ('C-Scan Initiation Procedure') at this visit, as described below.
C-Scan Initiation Procedure:
Subject will be connected to the C-Scan Track and system will be activated. The subject will be asked to ingest the C-Scan Capsule, in the presence of a physician with some water and water-soluble iodinated oral contrast medium indicated for radiographic examination of segments of the gastrointestinal tract and non-soluble fiber supplements.
Post ingestion, the subject will be discharged home with a Subject Instructions Packet which will include instructions on following routine daily regime (i.e., ingestion of contrast media 3 x 15ml per day and non-soluble fiber supplements X3 per day until capsule excretion) and record in a personal formatted diary the timing of specific activities such as bowel movements, daily activities and discomfort assessment via a validated scale. Also included will be Subject Satisfaction surveys that the subject should complete at the end of the procedure and return to the site upon completion.
Capsule Progress Days:
During the days in which the capsule is progressing within the subject, the subject is required to ingest contrast media (GE Omnipaque 350, FDA approved under NDA 018956) as well as non-soluble fiber supplements. The subject will be required to ingest daily dose (3 X 15 ml) of contrast media, to be consumed three times per day as well a non-soluble fiber 3x/day with normal diet.
Subjects will be required to undergo FIT procedure along with the C-Scan System procedure, per package insert instructions The subject will be provided with Laxadin (5 mg tablets) to be ingested according to the doctor recommendation, on an as needed basis. In routine procedures, subjects might be instructed to take 2 X 5 mg tablets 48-72 hours after ingestions (unless the capsule was already excreted).
Some subjects will be asked by the PI to come to the site for an abdominal X-Ray (fluoroscopy) while the capsule is still in the colon.
All subjects will be required to keep a log ('Subject's Diary') during procedure documenting general activities, contrast media intake, fibers intake, and food consumption, bowel movement, and system visual/auditory indicators.
Phone Call Follow-Up During-C-Scan Procedure :
After Capsule ingestion, the subject will be contacted by phone at least twice daily by the study team until the capsule has been excreted. The subject will be asked to provide feedback about the use of the device, excretion of the capsule, his/her general feeling or any inconvenience and will be reminded to complete the daily diary and discomfort assessment. The conversation with the subjects and their responses are tabulated and recorded in the study file.
C-Scan Procedure End:
Capsule procedure is completed upon capsule excretion or system auditory indication of 'End of Procedure'. Subjects will be asked to call the study team upon capsule excretion.
The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion. Return packaging and instructions will be provided. The subject will return with the Kit the diary, the questionnaire and all unused materials.
Follow-Up Phone Call Post-C-Scan Procedure End:
Follow up window is 1-3 days post-capsule excretion. Subject will be telephoned by study site to assess for any undesired events.
In case of doubt regarding capsule excretion, and per physician discretion, subjects may be referred to abdominal X-Ray to confirm capsule excretion.
Colonoscopy examination (optional)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluation of the performance of the C-Scan System in providing structural information on colonic polypoid lesions and masses in average risk vs. high risk subjects.
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects at averge risk for CRC | Experimental | Device: C-Scan SystemAll subjects are healthy who didn't have any known polyps in past colonoscopy and who arw candidates for CRC screening |
| Healthy subjects at high risk for CRC | Experimental | Device: C-Scan SystemSubjects who had polyps in former colonoscopy, subjects who have family history of CRC or subjects who have positive stool blood test. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female at the age of 40-80 years old
- Subjects who are ready to undergo the monitoring routine
- Subject provided signed informed consent
Key exclusion criteria (15 listed)
- Subjects with advanced cancer or other life threatening diseases or conditions
- Subjects with known history of dysphagia or other swallowing disorders
- Subjecta with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, 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 |
|---|---|---|
| C-Scan SystemAlso: C-Scan Cap, C-Scan TrackDuring C-Scan procedure the subject swallows the C-Scan cap. The capsule travels painlessly through the gastrointestinal tract, seeking polyps, the precursors of colorectal cancer. It is essential to increase the stool's contrast by ingesting radio-opaque material. During the passage of the capsule in the gastrointestinal tract, it transmits information to a recorder attached to the back. In order to collect data about the instantaneous localization of the capsule traveling in the colon additional sensors are embedded in the recorder on the back side. After the capsule is expelled, the data from the recorder is downloaded to an acquisition workstation. Later, the data is transferred to a processing workstation where dedicated software visualizes and analyses the data. | Device | Healthy subjects at averge risk for CRC, Healthy subjects at high risk for CRC |
Primary outcome
Safety- Number of incidents of trial duration above 300 hours
Time frame: 12 months
The duration of the study procedures will be no more than 12.5 days
Safety measurments of the C-Scan System regarding SUSAR
Time frame: 12 months
No Incidents of SUSAR according to CTCAE scale
Evaluation of the performance of the C-scan System in detecting polyps≥10 mm compared to FIT results
Time frame: 12 months
rate of Positive and Negative Agreement of C-Scan System compared to FIT in detecting subjects with polypoid lesions ≥10 mm
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.
- Individual participant dataSharing planned: No
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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.
Shlomo Lewkowicz, Dsc. study director
Check-Cap
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Scan System in people with Risk for Colorectal Cancer, run by Check-Cap Ltd. at 4 sites 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 3 inclusion and 15 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 4 sites 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?
Safety- Number of incidents of trial duration above 300 hours (time frame: 12 months). The study lists 3 primary outcomes in all. 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.