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

Launched by MEDTRONIC - MITG · Jan 29, 2008

Keywords

ClinConnect Summary

The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy. The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the abili...

Gender

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Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
• • Subject is between the ages of 18-75 years.
• • Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study)
• Exclusion Criteria:
• The presence of any of the following will exclude a subject from study enrollment:
• • Subject has dysphagia or any swallowing disorder
• • Subject has Congestive heart failure
• • Subject is known to suffer from diabetes
• • Subject has high degree of renal insufficiency
• • 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 pacemakers or other implanted electromedical devices.
• • 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 high risk for capsule retention: Crohn's disease, SB tumors, radiation enteritis, NSAID, surgical anastomosis,
• • 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, who intend to be during the study period, or are of child bearing potential and do not practice medically acceptable methods of contraception
• • Subject suffers from life threatening conditions
• • Subject currently participating in another clinical study