PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Intervention: PillCam COLON; Standard colonoscopy
Intervention description: The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.; Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Suspected colonic disease; Known colonic disease

Summary:

      To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant
      colonic pathologies when compared to colonoscopy in the target population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was referred for colonoscopy for one of the following reasons:

               -  Subjects over ≥ 50 years of age with one or more of the following clinical
                  symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood
                  Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent
                  onset.

               -  Any subject ≥ 18 years of age with:

                    -  Positive findings in the colon on a GastroIntestinal (GI) radiographic study

                    -  Personal history of colorectal cancer (CRC) or adenomatous colonic polyps
                       and at least 3 years since last colonoscopy

                    -  Suspected or known ulcerative colitis

        Exclusion Criteria:

          -  Subject has dysphagia

          -  Subject has congestive heart failure

          -  Subject has renal insufficiency

          -  Subject is known or is suspected to suffer from intestinal obstruction.

          -  Chronic use of laxatives

          -  Subject has a cardiac pacemakers or other implanted electro medical devices.

          -  Women who are either pregnant or nursing at the time of screening, who intend to be
             during the study period, or are of child-bearing potential and do not practice
             medically acceptable methods of contraception.

          -  Subject is expected to undergo MRI examination within 7 days after ingestion of the
             capsule.

          -  Subject has had prior abdominal surgery of the gastrointestinal tract other than
             uncomplicated procedures that would be unlikely to lead to bowel obstruction based on
             the clinical judgment of the investigator.

          -  Subject has any condition, which precludes compliance with study and/or device
             instructions.

          -  Age < 18 years

          -  Subject suffers from life threatening conditions

          -  Subject is currently participating in another clinical study

          -  Subject has known slow gastric emptying time