Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure

Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.

The study population will consist of subjects who fulfill at least one of the inclusion criteria and none of the exclusion criteria.

Inclusion Criteria:

• Subjects over ≥ 50 years of age scheduled for colorectal cancer screening
• Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.

• Subject ≥ 18 years of age with one of the following:

  • Positive findings (≥ 10 mm polyps) in the colon on a GI radiographic study (BE, CT scan, etc) OR
  • Personal history of colorectal cancer (CRC) or adenomatous polyps and ≥5 years since last colonoscopy

Exclusion Criteria:

• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Patient has significant renal insufficiency, heart disease or any other condition that the investigator would expect to increase the risk of complications from magnesium citrate, such as dehydration or electrolyte imbalance
• 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 a cardiac pacemaker or other implanted electro medical device.
• Subject has any allergy or other known contraindication to the medications used in the study
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
• Subject with gastrointestinal motility disorders
• Subject has known delayed gastric emptying
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception such as: surgical sterilization, approved hormonal contraceptives (i.e. birth control pills, Depo-Provera), barrier methods (i.e. condom or diaphragm) used with a spermicide and an intrauterine device (IUD)
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study