HealthyNCT05271656
Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
A study testing C-Scan System in people with Healthy, run by Check-Cap Ltd. at 3 sites in United States.
Trial summary
The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 May 2022to 26 Jul 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 45-75 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 no later than 60 days after C-Scan ingestion
- Maximal 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.
- History of the following:
- Colorectal polyps
- A personal history of CRC
- A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age
Show all 29Show fewer
- A history of inflammatory bowel disease of significant duration
- One of two (2) hereditary syndromes
- Known motility disorders:
- Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
- Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour
- Delayed gastric emptying.
- 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 a physician
- Any condition believed to have an increased risk for capsule retention, known strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such as esophageal diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
- Significant change in diameter and frequency of stool within the last 3 months.
- GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena.
- Implanted cardiac device or any other implanted active device
- Known sensitivity to iodine
- Acute kidney failure
- Known condition which precludes compliance or is contraindicated with study and/or device instructions.
- 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 within the four (4) weeks preceding the 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 trail using any investigational drug or device.
- Previous colonoscopy performed five (5) years or less before date of enrolment
- Subjects who tend to hyperhidrosis in the back area
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Health
New York, New York, 10016
Mayo Clinic
Phoenix, Arizona, 85259
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness.
During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion.
A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.
- Conditions
- Healthy
- 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 Optical colonoscopy
Subjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake of fiber pills 5 days, and contrast agent 48 hours prior to scheduled C-Scan capsule ingestion. 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 |
|---|---|---|
| C-Scan System | 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.
Demonstrate the accuracy of the C-Scan system in identifying subjects with colon polyps comparing to optical colonoscopy (OC).
For each subject the primary efficacy endpoints are dichotomous diagnosis using the C-Scan device (Test) and optical colonoscopy (Reference standard).
Reference standard will be considered "positive" ("1") if at least one polyp of at least 6 mm is found.
Test will be considered with elevated risk for polyps ("1") if either at least one polyp of at least 6 mm is found or long WGTT* occurred.
The above endpoints will be used to calculate sensitivity and specificity examined in the primary analysis.
*Long WGTT is defined as more than 73 hours for male and more than 97 hours for female.
Measured: 60 days
Secondary outcomes (5)
Negative predictive value for ruling out polyps of at least 10 mm.
Reference standard will be considered "positive" ("1") if at least one polyp of at least 10 mm is found.
Measured: 60 days
Sensitivity of C-Scan for detecting polyps of at least 10mm.
Reference standard will be considered "positive" ("1") if at least one polyp of at least 10 mm is found.
Measured: 60 days
Demonstrate the safety of the C-Scan System
Frequency of patients who experienced device or procedure related serious adverse events up to 7±3 days from capsule excretion. In addition, AEs and SAEs will be presented by severity and relation to device and procedure.
Measured: 7±3 days from capsule excretion
Demonstrate subjects' satisfaction and usability with the C-Scan System
This will be assessed via a descriptive analysis using a questionnaire
Measured: 7±3 days from capsule excretion
Demonstrate subjects' satisfaction with the C-Scan System compared to optical colonoscopy
This will be assessed via a descriptive analysis using a questionnaire
Measured: 4-10 days post colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start10 May 2022
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Why it stopped: Check Cap board of directors decision to stop all company activities including clinical trails
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check-Cap Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271656
- Sponsor's protocol ID
- CL-SY-02-0100
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
- ClinicalTrials.gov ID
- NCT05271656
- Acronym / sponsor ID
- CL-SY-02-0100
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Check Cap board of directors decision to stop all company activities including clinical trails
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Check-Cap Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 9 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 main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness.
During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion.
A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-Scan System | 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
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 45-75 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 no later than 60 days after C-Scan ingestion
- Maximal abdominal circumference < 125 cm.
Key exclusion criteria (29 listed)
- Subject who is not a suitable candidate for a colonoscopy
- Known history of dysphagia or other swallowing disorders.
- History of the following:
- Known motility disorders:
- Known IBD (Crohn's, Ulcerative Colitis)
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: Optical colonoscopySubjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake of fiber pills 5 days, and contrast agent 48 hours prior to scheduled C-Scan capsule ingestion. 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 | C-Scan System |
Primary outcome
Demonstrate the accuracy of the C-Scan system in identifying subjects with colon polyps comparing to optical colonoscopy (OC).
Time frame: 60 days
For each subject the primary efficacy endpoints are dichotomous diagnosis using the C-Scan device (Test) and optical colonoscopy (Reference standard). Reference standard will be considered "positive" ("1") if at least one polyp of at least 6 mm is found. Test will be considered with elevated risk for polyps ("1") if either at least one polyp of at least 6 mm is found or long WGTT* occurred. The above endpoints will be used to calculate sensitivity and specificity examined in the primary analysis. *Long WGTT is defined as more than 73 hours for male and more than 97 hours for female.
5 secondary outcomes
Negative predictive value for ruling out polyps of at least 10 mm.
Time frame: 60 days
Sensitivity of C-Scan for detecting polyps of at least 10mm.
Time frame: 60 days
Demonstrate the safety of the C-Scan System
Time frame: 7±3 days from capsule excretion
Demonstrate subjects' satisfaction and usability with the C-Scan System
Time frame: 7±3 days from capsule excretion
Demonstrate subjects' satisfaction with the C-Scan System compared to optical colonoscopy
Time frame: 4-10 days post colonoscopy
Results and safety
The study was stopped early (reason given: Check Cap board of directors decision to stop all company activities including clinical trails). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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, run by Check-Cap Ltd. at 3 sites in United States.
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 29 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: stopped early, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was stopped early (reason given: Check Cap board of directors decision to stop all company activities including clinical trails). 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?
Demonstrate the accuracy of the C-Scan system in identifying subjects with colon polyps comparing to optical colonoscopy (OC). (time frame: 60 days). 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 28 Jul 2023.