Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

Launched by MEDTRONIC - MITG · Feb 26, 2007

Keywords

ClinConnect Summary

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 ability to pursue normal daily activities immediately following the procedure . This multi-center prospective, cohort study will evaluate the performance of PCCE in visualizing the colon. Up to 394 subjects wi...

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
• Subject was referred for standard 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 FOBT, recent change of bowel habits
• • Any subject over 18 years of age with:
• • Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
• • Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
• • Suspected or known ulcerative colitis
• • Exclusion criteria
• The presence of any of the following will exclude a subject from study enrollment:
• • Subject has dysphagia
• • Subject has congestive heart failure
• • Subject has renal insufficiency
• • Subject is known or is suspected to suffer from intestinal obstruction.
• • Subject has a cardiac pacemaker or other implanted electro medical devices.
• • Subject is pregnant
• • 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 less than 18