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

Stopped early

Conditions studied: Colonic Diseases

In brief

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 Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)

Key facts

Study ID: NCT00440791
Run by: Medtronic - MITG
People needed: 40
Starts: 2006-06-01
Expected to finish: 2007-07-01
Last updated by the study team: 2019-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Mayo Clinic Arizona — Scottsdale, Arizona, United States
Indiana University Hospital — Indianapolis, Indiana, United States
Minnesota Gastroenterology — Minneapolis, Minnesota, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Private Medical Facility — New York, New York, United States
Oregon Health Sciences University — Portland, Oregon, United States
Rambam Medical Center — Haifa, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.