Development Study of Check-Cap Imaging System in Healthy Volunteers
Condition: Colo-rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the performance of Check-Cap Imaging System in healthy volunteers in a variety of
      operating scenarios.

      The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a
      capsule and the capsules do not have any radioactive source
    

Detailed description: 
      1. st visit - Subjects will be referred to the study by an advertisement in the local media

             -  The subjects will receive a preliminary explanation about the study procedure and
                required activities. If the subjects agree to participate in the study will be
                asked to sign the ICF

             -  Subjects will be screened for eligibility according to the inclusion/exclusion
                criteria.

             -  The date for their participation will be coordinated at their convenience

        2. nd visit - Subject will arrive to the company R&D lab and will receive detailed
           introduction about the procedure and instruction for the daily activities.

      (The total duration of Check-Cap Imaging System study for each subject is up to 4 days).

        -  Subjects will receive detailed instructions (verbally and written) about the normal
           operation of the C-Scan System and how to handle it during normal daily routine. They
           will be asked to document all their daily activity in a personal diary.

        -  The C-Scan Track will be attached to their lower back to test its functionality and the
           capsule will be attached to their abdomen to test the effect on data transmission during
           daily activities.

        -  The interference of the back recorder with the cloths (belt, bra etc.) will be monitored
           for any discomfort.

        -  Subjects will be asked to complete a personal diary which documents the time and
           duration of significant activities during the procedure such as meal times, sleeping
           times, physical activities etc.

        -  Some subjects will be instructed to be stationary during short sessions (10-20-30 min)
           and may read, watch TV or use the Internet. The localization data will be collected on a
           dedicated portable computer via these detectors.

        -  The monitoring routine for each subject will include but not limited to the following
           parameters:

             -  The well-being of the subject, and his/her daily routine: work, meals, driving,
                public transportation, mild sport, shower, sleep, other activities

             -  Inquiries about any discomfort caused by the recorder

             -  Inquiries about any discomfort or skin irritation caused by the patches.

             -  Inquiries about the function of the recorder as indicated by the recorder visual &
                indicators

             -  Ease of operation of the push buttons positioned on the recorder (reaching to the
                lower back with w/out direct vision (mirror)

             -  Responding to auditory and visual indicators position on the recorder

        -  Some subjects will be asked to continue carrying the back recorder system for few more
           days in order to evaluate the effects of the system on their daily activities.

        -  A subjective questionnaire will be filled by the subjects following each phase of the
           evaluation in order to solicit immediate feedback regarding any discomfort or complaint
           During the current development study the plan is to simulate some of these scenarios and
           evaluate the functionality of the back-recorder and communication with the capsule

        -  Subjects will continue their daily routine: work, sleep, shower, driving in car or
           public transportation, sit, stand, walk.

        -  Subjects should refrain from active sport such as jogging, physical exercise in the gym,
           swimming, sauna, any ball-games, skiing etc.

        -  Subjects should refrain from Flights, boat trips or long train travels during the
           monitoring procedure

        -  Subjects should try and stay away from areas with high electromagnetic fields such as:
           High voltage elect. Poles, transformation station, radio and TV transmitter station etc.

        -  Subjects should not be examined by CT or MRI (unless it is an emergency)

        -  Subjects who are working in an area with high electromagnetic field should not be
           examined by the capsule
    

Intervention name(s): C-Scan System
Intervention type(s): Device
Intervention description(s): Subjects will receive detailed instructions (verbally and written) about the normal operation of the recorder and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary (attached)
The recorder will be secured to their lower back to test its functionality
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subject population in this study will be composed of male and female subjects older
        than 25 and younger than 75 years old that volunteer for the experiment and qualify with
        the inclusion / exclusion criteria A total of Thirty (30) subjects will be enrolled in this
        study. All study participants will fit the body dimensions listed below (inclusion
        criteria) Efforts will be made to maintain balanced numbers between men and women and even
        distribution of ages.