Status:
TERMINATED
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Lead Sponsor:
Medtronic - MITG
Conditions:
Colonic Diseases
Eligibility:
All Genders
18+ years
Brief Summary
This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam ...
Detailed Description
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 sourc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00440791
Start Date
June 1 2006
End Date
July 1 2007
Last Update
July 31 2019
Active Locations (7)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
3
Minnesota Gastroenterology
Minneapolis, Minnesota, United States, 55446
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905