Status:
COMPLETED
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
Lead Sponsor:
Medtronic - MITG
Conditions:
Colonic Diseases
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of the night procedure in regards to colon cleansing level and capsule 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 Given® Diagnostic...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subject is between the ages of 50-75 years and has an indication to undergo colonoscopy: At least 75% of total cases OR
- Subject is 18-50 suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study - no more than 25% of total cases
- Exclusion criteria
- Subject has dysphagia or any swallowing disorder
- Subject has severe Congestive heart failure (NYHA II or IV)
- Subject has 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 judgement of the investigator
- Subject has a cardiac pacemaker or other implanted electromedical 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 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00951587
Start Date
February 1 2008
End Date
March 1 2010
Last Update
July 31 2019
Active Locations (2)
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1
Berufsgenossenschaftliche Universitätskliniken Bergmannsheil
Bochum, Germany, 44789
2
Knappschaftskrankenhaus Medizinische Universitaetsklinik
Bochum, Germany, 44892