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Trial record 1 of 1 for:    NCT03735407
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Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses (C-Scan)

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ClinicalTrials.gov Identifier: NCT03735407
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ceck Cap Ltd.

Brief Summary:

Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center, Single-arm, safety study Purpose: To demonstrate the safety of the Check-Cap C-Scan System Study Centers: Up to two (2) centers located in the United States Number of Participants: 45 healthy subjects Investigational Device: Check-Cap's C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan View.

Primary Objective: To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives: a. To evaluate subject's compliance b. To evaluate subject's satisfaction c. To collect data to improve the product's algorithm


Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Device: C-Scan procedure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Multi-center, Single-arm, safety study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Safety, Usability and Subject Compliance While Using Check- Cap's C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: C-Scan procedure
Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure
Device: C-Scan procedure

The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion.

o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,

Other Name: data collection to improve the product's algorithm




Primary Outcome Measures :
  1. Number of incidence of device and procedure related Serious Adverse Events (SAE) [ Time Frame: 6 Months ]
    The safety of the Check-Cap System will be evaluated by the incidence of device and procedure related Serious Adverse Events (SAE), as adjudicated by the Independent Physician Adjudicator.


Secondary Outcome Measures :
  1. Non-compliance rate of subjects (%) [ Time Frame: 6 months ]

    Subject compliance will be assessed by

    - Non-compliance rate throughout the study via diary completion by the subject Specific questionnaire. completed by remote subject monitoring (via telephone) The rate will be measured in a percentage scale (1-100%) Score less then 50% will be considered as a compliance failure


  2. To evaluate subject's satisfaction [ Time Frame: 8 weeks ]

    Subject satisfaction will be established by:

    Designated questionnaire that focuses on patient's impressions regarding tolerance and potential safety concerns, which will be provided to the subjects after the C-Scan procedure and after the colonoscopy procedure. Acceptance criteria was defined as average score >3.5 (1- low satisfaction to 5- high satisfaction), which represent high satisfaction with the safety and tolerance of the C-scan system.

    Comparing patient's satisfaction with C-Scan procedure and colonoscopy procedure




Information from the National Library of Medicine

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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:

  1. Male or female at the age of 40-80 years' old.
  2. Subject provided signed informed consent.
  3. Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.
  4. Subjects able and agrees to undergo colonoscopy procedure.
  5. BMI > 22 and ≤ 35.
  6. Maximum body (abdominal) circumference < 120 cm.
  7. Has at least 3 bowel movements per week
  8. A colonoscopy procedure is pre-scheduled within 60 days

Exclusion Criteria:12.3 Exclusion Criteria

  1. Known history of dysphagia or other swallowing disorders.
  2. History of the followings: Inflammatory Bowel Disease (IBD) including Crohn's disease or Ulcerative, Colitis, Meckel's Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' discretion), or a history of small bowel obstruction.
  3. Known motility disorders:

i. Chronic Constipation: less than 3 bowel movements/week, w/out the use of laxatives.

ii. Delayed gastric emptying. iii. Narcotic use d. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion with the exception of appendectomy, cholecystectomy and hysterectomy e. Any condition believed to have an increased risk for capsule retention, strictures, bowel adhesion or other obstacles to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies (e.g. due to obstructions or NSAID enteropathy) as determined by physician discretion.

f. Has a cardiac device (e.g. pacemaker or ICD-Implantable Cardioverter Defibrillator) or any other active implanted device g. Known sensitivity to iodine, or with known kidney failure. h. Known condition which precludes compliance or is contraindicated with study and/or device instructions.

i. Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month j. Known condition of drug abuse and/or alcoholism. k. 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.

l. 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): NCT03735407


Contacts
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Contact: Christopher Hawryluk, CRC 1-6465017984 Christopher.Hawryluk@nyulangone.org
Contact: Seth Gross, MD 1-6465017984 Seth.Gross@nyulangone.org

Locations
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United States, Minnesota
Mayoclinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Crystal Tholen, CRC    507-538-1361    tholen.crystal@mayo.edu   
Contact: Elizabeth Rajan, Prof. PI    507)538-1361      
Sponsors and Collaborators
Ceck Cap Ltd.
Investigators
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Principal Investigator: Seth Gross NYU Langone Health

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Responsible Party: Ceck Cap Ltd.
ClinicalTrials.gov Identifier: NCT03735407     History of Changes
Other Study ID Numbers: CL-SY-02-0096
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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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: No
Pediatric Postmarket Surveillance of a 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