Status:
COMPLETED
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
Lead Sponsor:
Medtronic - MITG
Conditions:
Bowel Diseases
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on colon cleansing level and excretion rate.
Detailed Description
The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The PillCam® platform...
Eligibility Criteria
Inclusion
- Subjects over ≥ 50 years of age scheduled for colorectal cancer screening
- 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, or diarrhea/constipation of recent onset.
- Subject ≥ 18 years of age with one of the following:
- Positive findings (≥ 10 mm polyps) in the colon on a GI radiographic study (BE, CT scan, etc) OR
- Personal history of colorectal cancer (CRC) or adenomatous polyps and ≥5 years since last colonoscopy
Exclusion
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Patient has significant renal insufficiency, heart disease or any other condition that the investigator would expect to increase the risk of complications from magnesium citrate, such as dehydration or electrolyte imbalance
- 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 pacemaker or other implanted electro medical device.
- 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 any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
- Subject with gastrointestinal motility disorders
- Subject has known delayed gastric emptying
- 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, or are of child-bearing potential and do not practice medically acceptable methods of contraception such as: surgical sterilization, approved hormonal contraceptives (i.e. birth control pills, Depo-Provera), barrier methods (i.e. condom or diaphragm) used with a spermicide and an intrauterine device (IUD)
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00885235
Start Date
October 1 2008
End Date
August 1 2009
Last Update
July 31 2019
Active Locations (4)
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1
University of Indiana Hospital
Indianapolis, Indiana, United States, 46202
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
Digestive Care Inc.
Beavercreek, Ohio, United States, 45440
4
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320