Healthy SubjectsNCT05268406
Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
A study testing C-Scan System in people with Healthy Subjects, run by Check-Cap Ltd. at 10 sites in Israel.
Trial summary
The purpose of the first part of the study (subgroup R\&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- 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
- 800 participants
- Where
- 10 sitesIsrael
- Study dates
- 29 Jul 2020to 31 Aug 2023
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female at the age of 50-75 years old
- Able to provide a signed informed consent.
- Willing and able to comply with the specified study requirements and can be contacted by telephone.
- Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.*
- Maximum body (abdominal) circumference < 125 cm.
Who cannot join
- Subject who is not a suitable candidate for a colonoscopy
- Known history of dysphagia or other swallowing disorders.
- Third (3rd) and fourth (4th) exclusion criteria are applicable to the pre-pivotal subgroup only:
- History of the following:
- Previous colon polyps
- Personal history of CRC
Show all 28Show fewer
- Family history of CRC or adenomatous polyps diagnosed in a relative before age 60 years
- History of inflammatory bowel disease
- Having an inherited syndrome (Lynch syndrome, FAB)
- GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena
- Known motility disorders:
- Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
- Delayed gastric emptying.
- Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour.
- Known IBD (Crohn's, ulcerative Colitis)
- Prior history of gastrointestinal tract surgery.
- Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion.
- Any condition believed to have an increased risk for capsule retention, known strictures, any prior episode of bowel obstruction: known bowel adhesion, any 'obstacles' to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies or incomplete colonoscopies as determined by physician discretion.
- Significant change in diameter and frequency of stool within the last 3 months
- Has an implanted cardiac device or any other implanted active device
- Known sensitivity to iodine or hyperthyroidism
- Acute kidney failure
- Known condition which precludes compliance or is contraindicated with study and/or device instructions.
- Has any procedure requiring contrast agent or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion
- Nuclear imaging procedure during 4 weeks before C-Scan procedure
- Known condition of opioid use disorder and/or alcoholism.
- Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization(
- Concurrent participation in another clinical trial using any investigational drug or device.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Israel10 sites, 8 recruiting
- Recruiting
Emek Medical Center
Afula
Ian Gralnek, Professor
Ian Gralnek, Professor
- Terminated
Soroka Medical Center
Beersheba, 3030000
- Recruiting
Bnei Zion Medical center
Haifa
Tova Rainis, M.D
Tova Rainis, M.D
- Recruiting
Lin- Clalit
Haifa
Hisham Shuli, M.D
Hisham Shuli, M.D
- Recruiting
Rambam Medical Center
Haifa
Elizabeth half, M.D
Elizabeth Half, M.D
- Terminated
Talpiot- Clalit
Jerusalem
- Recruiting
Meir Medical Center
Kfar Saba
Yehuda Ringel, Professor
Yehuda Ringel, Professor
- Recruiting
Galil Medical Center
Nahariya
Wisam Sbeit, M.D
Wisam Sbeit, M.D
- Recruiting
Laniado Medical Center
Netanya
Atara Vatury, aTvatury@laniado.org.il
Benny Shpak, MD
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Nadir Arber, Professor, nadira@tlvmc.gov.il
Nadir Arber, Professor
About this study
The purpose of the first part of the study (subgroup R\&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. The purpose of the second part of the study (subgroup pre-pivotal) is to determine the ability of the C-Scan System to identify elevated risk subjects
- Conditions
- Healthy Subjects
- 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
Subjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake approximately 48 hours prior to the planned C-Scan procedure start. C-Scan system intervention includes ingestion of the C-Scan Cap and attachment of the C-Scan track to the subject's lower back. The subject is required to keep the C-Scan Track attached to the lower back and to continue intake of contrast agent and dietary fiber pills until the C-Scan Cap's natural excretion. Standard of care optical colonoscopy will be performed within 60 days from the C-Scan Cap ingestion.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy Receives: Device: C-Scan System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the ability of the C-Scan System to identify elevated risk subjects
Sensitivity for detecting subjects with elevated risk for polyps
Measured: 60 days
Determine the ability of the C-Scan System to identify elevated risk subjects
Specificity for detecting subjects with elevated risk for polyps
Measured: 60 days
Secondary outcomes (4)
Incidence of device or procedure related adverse events
Analysis of safety data
Measured: Up to 7 days post C-Scan procedure completion
Satisfaction with the C-Scan procedure assessed by a questionnaire
Satisfaction questionnaire to be completed by the subject
Measured: Up to 7 days post C-Scan procedure completion
Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire
Satisfaction questionnaire to be completed by the subject
Measured: Up to 7 days post colonoscopy
Evaluate the Whole Gut Transit Time
Time elapsed from capsule ingestion to excretion
Measured: During the C-Scan procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start29 Jul 2020
- Primary completion31 May 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadir Arber, Professor, Principal investigator, Tel Aviv Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268406
- Sponsor's protocol ID
- CL-SY-01-0099
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 8 Dec 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
- ClinicalTrials.gov ID
- NCT05268406
- Acronym / sponsor ID
- CL-SY-01-0099
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 7 Mar 2022 (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.
The purpose of the first part of the study (subgroup R\&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. The purpose of the second part of the study (subgroup pre-pivotal) is to determine the ability of the C-Scan System to identify elevated risk subjects
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: C-Scan SystemAll study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female at the age of 50-75 years old
- Able to provide a signed informed consent.
- Willing and able to comply with the specified study requirements and can be contacted by telephone.
- Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.*
- Maximum body (abdominal) circumference < 125 cm.
Key exclusion criteria (28 listed)
- Subject who is not a suitable candidate for a colonoscopy
- Known history of dysphagia or other swallowing disorders.
- Third (3rd) and fourth (4th) exclusion criteria are applicable to the pre-pivotal subgroup only:
- History of the following:
- GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena
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 SystemSubjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake approximately 48 hours prior to the planned C-Scan procedure start. C-Scan system intervention includes ingestion of the C-Scan Cap and attachment of the C-Scan track to the subject's lower back. The subject is required to keep the C-Scan Track attached to the lower back and to continue intake of contrast agent and dietary fiber pills until the C-Scan Cap's natural excretion. Standard of care optical colonoscopy will be performed within 60 days from the C-Scan Cap ingestion. | Device | Single arm |
Primary outcome
Determine the ability of the C-Scan System to identify elevated risk subjects
Time frame: 60 days
Sensitivity for detecting subjects with elevated risk for polyps
Determine the ability of the C-Scan System to identify elevated risk subjects
Time frame: 60 days
Specificity for detecting subjects with elevated risk for polyps
4 secondary outcomes
Incidence of device or procedure related adverse events
Time frame: Up to 7 days post C-Scan procedure completion
Satisfaction with the C-Scan procedure assessed by a questionnaire
Time frame: Up to 7 days post C-Scan procedure completion
Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire
Time frame: Up to 7 days post colonoscopy
Evaluate the Whole Gut Transit Time
Time frame: During the C-Scan procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
Nadir Arber, Professor principal investigator
Tel Aviv Medical Center, Israel
10 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 Healthy Subjects, run by Check-Cap Ltd. at 10 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 5 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanit Brenner- Lavie, PhD (97248303401, hanit.brenner@check-cap.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the ability of the C-Scan System to identify elevated risk subjects (time frame: 60 days). The study lists 2 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 8 Dec 2022.