Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions
Condition: Polypoid Lesions
Study type: Interventional

Summary: 
      The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in
      providing structural information on colonic polypoid lesions and masses, as an adjacent tool
      to FIT.
    

Detailed description: 
      The subject will be invited to come to the clinic to sign the ICF and other related
      documents. Then they'll ingest the capsule typically during the morning hours. The subjects
      will be connected to the C-Scan Track and system's activation the subject will be asked to
      ingest the C-Scan Capsule with some water and contrast media, in the presence of a physician.

      Post ingestion, the subject will be discharged home with clear instructions on the procedure.
      The subject should avoid intensive physical exercise during procedure or any extreme
      activities. The subject should make an effort to stay at home or other familiar surroundings,
      and may continue daily activities such mobile/computer/TV use, shower, sleep or eat. Details
      on allowed and restricted activities are listed in app. 4 The subject will be required to
      ingest daily dose (3 X 15-17ml) of contrast media, to be consumed three times per day with
      normal diet. Also on a need based the subject would be provided with laxadine (5 mg tablets)
      to be ingested according to the doctor recommendation.

      During capsule procedure the subjects will be contacted by phone several times daily by the
      site clinical study team (or by dedicated external trained medical personnel), to assure the
      subjects well-being and to monitor for any change or discomfort and for procedure progress.
      Subjects may be also monitored by the technical team (either at home or at the clinic), who
      may need to examine the system or inquire the subjects about the system visual/auditory
      indicators.

      The subjects will be provided with a dedicated capsule collection kit, to assist the subjects
      in collecting the capsule. Subjects will be instructed to retrieve the capsule upon
      excretion.

      Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of
      'End of Procedure'.

      Patients will be instructed to return the C-Scan Capsule and C-Scan Track to the clinic for
      analysis.

      All subjects will be scheduled for optical colonoscopy to be performed within one month
      following capsule procedure.

      C-Scan Procedure Analysis:

      Two to three licensed gastroenterologist physicians, will be trained with reviewing and
      analyzing C-Scan System scans, to serve as independent reviewers. A reviewing forum
      consisting of at least one independent trained gastroenterologist physician and at least 2
      expert Check-Cap reviewers that will jointly review all the cases. The reviewing forum will
      be blinded to the FIT and colonoscopy results of the examined patients..). Analysis will be
      performed on a per patient basis for the existence or non-existence of a finding that may be
      a polyp. This per patient finding will be compared with the FIT, and a colonoscopy will be
      performed for verification.
    

Intervention name(s): C-Scan System
Intervention type(s): Device
Intervention description(s): To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy
To evaluate the safety of the C-Scan Capsule System procedure
Other intervention name(s): Colon capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: average risk CRC screening; Non compliant patients for CRC screening; Counterindicated patients for colonoscopy