Status:
UNKNOWN
PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
Lead Sponsor:
Bethesda Krankenhaus
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Brief Summary
Purpose of study: To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects S...
Eligibility Criteria
Inclusion
- Subject is \>/= 18 years
- Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
- Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum \>45 min), adverse reaction to sedation requiring termination of colonoscopy
Exclusion
- Subject has dysphagia or any swallowing disorder
- Subject has severe congestive heart failure or renal insufficiency
- Subject with high risk for capsule retention
- Subject has a cardiac pacemakers or other implanted electromedical devices
- Subject has any allergy or other contraindication to the medications used in the study
- Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
- Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
- Colonoscopy had been performed by a physician who has experience of \<1000 complete colonoscopies
- Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
- Time interval between incomplete colonoscopy and capsule endoscopy \>30 days
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01480635
Start Date
June 1 2010
End Date
October 1 2012
Last Update
November 29 2011
Active Locations (6)
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1
Bethesda Krankenhaus Bergedorf
Hamburg, Hamburg, Germany, 21029
2
Asklepios Klinik Altona
Hamburg, Hamburg, Germany, 22763
3
Ev. Krankenhaus Düsseldorf
Düsseldorf, Germany, 40217
4
Gastroenterologische Praxis
Düsseldorf, Germany, 40227