Performance Evaluation of the NaviCam SB Capsule Endoscope System for the Diagnosis of Small Bowel Diseases

Exclusion Criteria

• •1. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule;
• •2. Patient with known gastrointestinal motility disorders;
• •3. Patient with known or suspected gastrointestinal obstruction, stenosis or fistula;
• •4. Patient with known or suspected delayed gastric emptying;
• •5. Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions;
• •6. Patient has any allergy or other known contraindication or intolerance to the medications used in the study;
• •7. Patient has any condition, which precludes compliance with study and/or device instructions;
• •8. Women who are either pregnant or nursing at the time of screening;
• •9. Concurrent participation in another clinical trial using any investigational drug or device;
• •10. Patient suffers from a life-threatening condition;
• •11. Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters;
• •12. Patients with pace-maker or implantable cardioverter other implantable electronic medical device;
• •13. Patient with an easily magnetized metal part;
• •14. Patient requires endoscopic placement of the capsule;
• •15. Others considered by the investigator not suitable for this study.