Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
Condition: Colo-rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

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
    

Detailed description: 
      Overall Design: Up to 45 healthy subjects will participate in this study. Subjects to be
      enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on
      the following symptoms or by being classified as higher than average risk based on one or
      more of the following:

        -  Surveillance - Significant findings in previous optical colonoscopy

        -  Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy

        -  Diagnostic - Polyps detected in previous optical colonoscopy (community setting)
           referred for polypectomy

        -  Diagnostic - Positive FIT (Fecal Immunochemical Test)

        -  Diagnostic - one or more of the typical symptoms:

        -  abdominal pain

        -  Change in bowel habits

        -  Anemia or overt bleeding in stool

        -  Significant weight loss

        -  First degree relatives of CRC (Colo-Rectal Cancer)subjects Alternatively, average risk
           based on their age and demographics referred for screening for polyps

      Each subject will receive a comprehensive explanation regarding the study nature. During this
      process, and per ethical committee approval, subjects may be asked several questions (over
      the phone) regarding their medical background for preliminary assessment of eligibility. Once
      informed consent is obtained, a thorough evaluation of subject's eligibility will be
      performed based on inclusion / exclusion criteria.

      Eligible subjects will be required to undergo FIT procedure, per package insert instructions,
      within pre-defined timelines. All subjects will be scheduled to undergo capsule procedure, to
      be followed later on with optical colonoscopy procedure.

      One to three days following end of C-Scan procedure the subjects will be contacted by phone
      by the clinical coordinator to follow-up on the subject well-being. Same follow-up procedures
      will be applied one to three days following Optical Colonoscopy procedure. Medical history
      and concomitant medication information will be collected for all subjects.

      Study Duration: The duration of study participation for each subject is expected to be
      approximately 8-10 weeks. The total study duration across all patients is expected to be
      approximately 6 months, dependent upon subject recruitment rate.

      C-Scan Procedure: Subjects will be instructed to skip breakfast or lunch on the day of C-Scan
      Capsule ingestion to expedite gastric passage. Liquids are allowed.

      The subjects will be connected to the C-Scan Track and after successful system's activation
      (BIT - built in test), the subject will be asked to ingest the C-Scan Capsule with some
      water, contrast media (GE Omnipaque 350) and non-soluble fiber, in the presence of a
      physician investigator or designee. The subject will also be provided with an RF watch. A
      representative of the sponsor will attend the ingestion procedure, as needed to assure proper
      activation.

      Post ingestion, the subject will receive detailed instructions about the daily routine and
      activities as well as use of the RF watch and then will be discharged home with written
      instructions on the procedure Instructions for use (IFU), daily diary, FIT kit and capsule
      return kit.

      FIT Procedure: All subjects will be required to perform FIT procedure using [OC-Light] FIT
      Kit prior or during the capsule procedure Capsule Return: Capsule procedure is completed upon
      capsule excretion or system auditory indication of 'End of Procedure'. Subjects will be
      instructed to inform the study coordinator or designee upon capsule excretion
    

Intervention name(s): C-Scan procedure
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): data collection to improve the product's algorithm
Intervention model: Single Group Assignment
Intervention model description: Prospective, Multi-center, Single-arm, safety study
Masking: None (Open Label)
Primary purpose: Diagnostic