Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy
Condition: Colo-rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in
      the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home
      Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per
      person, (1 capsule at a time) The primary objective of the study is to monitor the
      variability of the motility of the MD1 capsules in the Gastrointestinal tract of human
      subjects with and without polyps in previous Colonoscopy.
    

Detailed description: 
      The subject population in this study will be composed of male and female subjects older than
      40 and younger than 80 years old who volunteer for the experiment and qualify with the
      inclusion / exclusion criteria A total of one hundred (100) subjects will be enrolled in this
      study. All study participants will be examined by the MD1 capsules, 2-5 capsules per person,
      one capsule at a time. Efforts will be made to maintain balanced numbers between men and
      women and even distribution of ages.

      The study will be conducted by phases:

      A 15-20 Men with polyps in previous Colonoscopy (2-3 repeated ingestions) B. 10-20 Men With
      no polyps in previous Colonoscopy (1-2 repeated ingestions) C. 15-20 Women with polyps in
      previous Colonoscopy (2-3 repeated ingestions) D. 10-20 Women With no polyps in previous
      Colonoscopy (1-2 repeated ingestions) E Same as A-D with the use of prokinetic drugs F. Same
      as A-D with different type of capsules (lower weight and/or rounded caps on both sides).

      The total duration of the study for each subject is two-four weeks. Each subject will ingest
      2-5 capsules, one at a time, with at least 1 week apart between repeated ingestion

        1. st Visit (phone interview) - 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.

        2. nd Visit - Once informed consent is obtained, a thorough evaluation of subject's
           eligibility will be performed based on inclusion / exclusion criteria.

      Consent to participate in this study must be given in writing. The signed informed consent
      will remain in subject's file. A signed copy will be given to the subject.

      Subject will ingest the capsule (in the presence of a medical professional).

      Post ingestion, the subject will receive detailed instructions about the daily routine and
      activities and then will be discharged home with written instructions on the procedure (IFU -
      Instructions for use). The subject should avoid intensive physical exercise during the
      procedure or any extreme activities. The subject should make an effort to stay at home or
      other familiar surroundings (within 2 hours of driving from the clinic), and may continue
      daily activities such mobile/computer/TV (Television) use, shower, sleep or eat.

      Details on allowed and restricted activities are listed in the Information For use which is
      included in the Kit).

      All subjects will be provided with a contact card with study details and site contact
      information (24/7).

      Discharged home
    

Intervention name(s): MDI
Intervention type(s): Device
Intervention description(s): Capsule MD1 (Motility dummy 1)
Other intervention name(s): Capsule MD1 (Motility dummy 1)
Intervention model: Single Group Assignment
Intervention model description: Multi-Center, Open, Home Monitoring, Prospective Study
Masking: None (Open Label)
Primary purpose: Diagnostic