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Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects (CRC)

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: NCT04038736
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Check-Cap Ltd.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Risk for Colorectal Cancer Device: C-Scan System Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: 3 independent reviewers, licensed physicians, trained with reviewing and analyzing C-Scan System scans, will evaluate all study subjects original scans for potential findings, including type, location and size. All reviewers will be blinded to the subject groups (symptoms, classification etc.)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: Healthy subjects at averge risk for CRC
All subjects are healthy who didn't have any known polyps in past colonoscopy and who arw candidates for CRC screening
Device: C-Scan System
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.
Other Name: C-Scan Cap, C-Scan Track

Experimental: Healthy subjects at high risk for CRC
Subjects who had polyps in former colonoscopy, subjects who have family history of CRC or subjects who have positive stool blood test.
Device: C-Scan System
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.
Other Name: C-Scan Cap, C-Scan Track




Primary Outcome Measures :
  1. 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

  2. Safety measurments of the C-Scan System regarding SUSAR [ Time Frame: 12 months ]
    No Incidents of SUSAR according to CTCAE scale

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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): NCT04038736


Contacts
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Contact: Shlomo Lewkowicz, Dsc. 524747234 ext 972 Shlomo.Lewkowicz@check-cap.com
Contact: Hedva Taanach-Rubin, Bsc. 525380377 ext 972 hedva.taanach@check-cap.com

Locations
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Israel
Bnai Zion Medical Center Recruiting
Haifa, North, Israel, 33391
Contact: Tova Rainis, D.Sc, PI    97248359426    tovarainis@gmail.com   
Contact: Leonid Shpoker, B.Sn, CRC    97248359426    leonid.shpoker@b-zion.org.il   
Rambam Medical Center Not yet recruiting
Haifa, North, Israel, 3525408
Contact: Elizabeth Half, MD    972-4-7771777 ext 1    E_Half@rambam.health.gov.il   
Contact: DIkla Chen, Bsc    972-4-7771777 ext 1    D_CHEN@rambam.health.gov.il   
Haemek Medical Center Recruiting
Afula, Israel
Contact: ian ian gralnek, Prof.    04-6495552    ian_gr@clalit.org.il   
Tel Aviv Sorasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Nadir Arber, Prof'    +972-3-6974896      
Principal Investigator: Menachem Moskowicz, MD         
Sponsors and Collaborators
Check-Cap Ltd.
Investigators
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Study Director: Shlomo Lewkowicz, Dsc. Check-Cap
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Responsible Party: Check-Cap Ltd.
ClinicalTrials.gov Identifier: NCT04038736    
Other Study ID Numbers: CL-SY-01-0098
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases