Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
Condition: Risk for Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      Study Population:

      A total of 300 healthy subjects, Male or female, at average or high risk for CRC will be
      enrolled for the study.

      Visit 1: C-Scan Procedure Visit This visit is performed in order to ensure that the subject
      continues to meet all inclusion and has no exclusion criteria, and has had adequate time to
      review the consent form and to ask questions. Once it has been determined that the subject
      meets all inclusion and has no exclusion criteria, and the subject chooses to participate in
      the study, the consent form will be signed and dated by all appropriate parties prior to
      execution of study-specific assessments. Signing the informed consent form signifies
      enrollment in the clinical study.

      Capsule ingestion will take place at this visit. Additionally, the subject will receive
      detailed training session and instructions including explanation from the site study team
      about the device, its usage and the required documentation described below. Following subject
      training, the Capsule will be ingested ('C-Scan Initiation Procedure') at this visit, as
      described below.

      C-Scan Initiation Procedure:

      Subject will be connected to the C-Scan Track and system will be activated. The subject will
      be asked to ingest the C-Scan Capsule, in the presence of a physician with some water and
      water-soluble iodinated oral contrast medium indicated for radiographic examination of
      segments of the gastrointestinal tract and non-soluble fiber supplements.

      Post ingestion, the subject will be discharged home with a Subject Instructions Packet which
      will include instructions on following routine daily regime (i.e., ingestion of contrast
      media 3 x 15ml per day and non-soluble fiber supplements X3 per day until capsule excretion)
      and record in a personal formatted diary the timing of specific activities such as bowel
      movements, daily activities and discomfort assessment via a validated scale. Also included
      will be Subject Satisfaction surveys that the subject should complete at the end of the
      procedure and return to the site upon completion.

      Capsule Progress Days:

      During the days in which the capsule is progressing within the subject, the subject is
      required to ingest contrast media (GE Omnipaque 350, FDA approved under NDA 018956) as well
      as non-soluble fiber supplements. The subject will be required to ingest daily dose (3 X 15
      ml) of contrast media, to be consumed three times per day as well a non-soluble fiber 3x/day
      with normal diet.

      Subjects will be required to undergo FIT procedure along with the C-Scan System procedure,
      per package insert instructions The subject will be provided with Laxadin (5 mg tablets) to
      be ingested according to the doctor recommendation, on an as needed basis. In routine
      procedures, subjects might be instructed to take 2 X 5 mg tablets 48-72 hours after
      ingestions (unless the capsule was already excreted).

      Some subjects will be asked by the PI to come to the site for an abdominal X-Ray
      (fluoroscopy) while the capsule is still in the colon.

      All subjects will be required to keep a log ('Subject's Diary') during procedure documenting
      general activities, contrast media intake, fibers intake, and food consumption, bowel
      movement, and system visual/auditory indicators.

      Phone Call Follow-Up During-C-Scan Procedure :

      After Capsule ingestion, the subject will be contacted by phone at least twice daily by the
      study team until the capsule has been excreted. The subject will be asked to provide feedback
      about the use of the device, excretion of the capsule, his/her general feeling or any
      inconvenience and will be reminded to complete the daily diary and discomfort assessment. The
      conversation with the subjects and their responses are tabulated and recorded in the study
      file.

      C-Scan Procedure End:

      Capsule procedure is completed upon capsule excretion or system auditory indication of 'End
      of Procedure'. Subjects will be asked to call the study team upon capsule excretion.

      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. Return packaging and instructions will be provided. The subject will return with
      the Kit the diary, the questionnaire and all unused materials.

      Follow-Up Phone Call Post-C-Scan Procedure End:

      Follow up window is 1-3 days post-capsule excretion. Subject will be telephoned by study site
      to assess for any undesired events.

      In case of doubt regarding capsule excretion, and per physician discretion, subjects may be
      referred to abdominal X-Ray to confirm capsule excretion.

      Colonoscopy examination (optional)
    

Intervention name(s): C-Scan System
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): C-Scan Cap, C-Scan Track
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)
Primary purpose: Diagnostic