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Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05271656
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Check-Cap Ltd.

Brief 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. 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 attached to the subject's back. Subjects then will be asked to swallow the C-Scan capsule and will be released from the clinic to their routine. Subjects will be asked to ingest contrast agent fluid and fiber pills starting 48 hours before capsule swallowing, up to capsule natural excretion.

Standard colonoscopy procedure will be performed within 60 days following the C-Scan Cap swallowing.


Condition or disease Intervention/treatment Phase
Healthy Device: C-Scan System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 952 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The Sponsor and the C-Scan data analysis team shall be blind to subject's optical colonoscopy data until the C-Scan report is created.
Primary Purpose: Screening
Official Title: Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Actual Study Start Date : May 10, 2022
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : April 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C-Scan System
All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy
Device: C-Scan System
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.
Other Name: Optical colonoscopy




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Negative predictive value for ruling out polyps of at least 10 mm. [ Time Frame: 60 days ]
    Reference standard will be considered "positive" ("1") if at least one polyp of at least 10 mm is found.

  2. Sensitivity of C-Scan for detecting polyps of at least 10mm. [ Time Frame: 60 days ]
    Reference standard will be considered "positive" ("1") if at least one polyp of at least 10 mm is found.

  3. Demonstrate the safety of the C-Scan System [ Time Frame: 7±3 days from capsule excretion ]
    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.

  4. Demonstrate subjects' satisfaction and usability with the C-Scan System [ Time Frame: 7±3 days from capsule excretion ]
    This will be assessed via a descriptive analysis using a questionnaire

  5. Demonstrate subjects' satisfaction with the C-Scan System compared to optical colonoscopy [ Time Frame: 4-10 days post colonoscopy ]
    This will be assessed via a descriptive analysis using a questionnaire



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects 50-75 years old
  2. Able to provide a signed informed consent.
  3. Willing and able to comply with the specified study requirements and can be contacted by telephone.
  4. Scheduled for colonoscopy procedure no later than 60 days after C-Scan ingestion
  5. Maximal abdominal circumference < 125 cm.

Exclusion Criteria:

  1. Subject who is not a suitable candidate for a colonoscopy
  2. Known history of dysphagia or other swallowing disorders.
  3. History of the following:

    1. Colorectal polyps
    2. A personal history of CRC
    3. A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age
    4. A history of inflammatory bowel disease of significant duration
    5. One of two (2) hereditary syndromes
  4. Known motility disorders:

    1. Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
    2. Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour
    3. Delayed gastric emptying.
  5. Known IBD (Crohn's, Ulcerative Colitis)
  6. Prior history of gastrointestinal tract surgery.
  7. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician
  8. 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 diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
  9. Significant change in diameter and frequency of stool within the last 3 months.
  10. GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena.
  11. Implanted cardiac device or any other implanted active device
  12. Known sensitivity to iodine
  13. Acute kidney failure
  14. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
  15. 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
  16. Nuclear imaging procedure within the four (4) weeks preceding the C-Scan procedure.
  17. Known condition of opioid use disorder and/or alcoholism.
  18. 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).
  19. Concurrent participation in another clinical trail using any investigational drug or device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05271656


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Crystal Lavey    507-538-1361    lavey.crystal@mayo.edu   
Principal Investigator: Elizabeth Rajan, M.D.         
Sponsors and Collaborators
Check-Cap Ltd.
Additional Information:
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Responsible Party: Check-Cap Ltd.
ClinicalTrials.gov Identifier: NCT05271656    
Other Study ID Numbers: CL-SY-02-0100
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical