Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure

Exclusion Criteria

• •\-
• •HyGIeaCare:
• •1. Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
• •2. Patient is treated long-term with narcotics.
• •3. Patient does not have any of the contraindications listed below:
• •1. Cardiac: Congestive heart failure (NYHA class III or IV or Ejection Fraction \<50%)
• •2. GastrointestinaI: Intestinal perforation, carcinoma of the rectum, Fissures or fistula, Severe hemorrhoids, Abdominal hernia, recent colon or rectal surgery, abdominal surgery
• •3. Genitourinary: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
• •4. Abdominal surgery within the last 6 months
• •5. Pregnancy
• •PillCam COLON:
• •1. Subject has dysphagia or any swallowing disorder
• •2. Subject has congestive heart failure
• •3. Subject has Diabetes type I.
• •4. Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
• •5. Subject has a cardiac pacemaker or other implanted electro medical device.
• •6. Subject has any allergy or other known contraindication to the medications used in the study
• •7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• •8. Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
• •9. Subject with gastrointestinal motility disorders
• •10. Subject has known delayed gastric emptying
• •11. Subject has any condition, which precludes compliance with study and/or device instructions.
• •12. 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.
• •13. Subject suffers from life threatening conditions
• •14. Subject currently participating in another clinical study