PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
NCT ID: NCT01480635
Last Updated: 2011-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
74 participants
OBSERVATIONAL
2010-06-30
2012-10-31
Brief Summary
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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
Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months
Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Incomplete Colonoscopy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Bethesda Krankenhaus
OTHER
Responsible Party
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Principal Investigators
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Martin Keuchel, Dr.
Role: PRINCIPAL_INVESTIGATOR
Bethesda Krankenhaus Bergedorf, Hamburg, Germany
Locations
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Bethesda Krankenhaus Bergedorf
Hamburg, City state of Hamburg, Germany
Asklepios Klinik Altona
Hamburg, City state of Hamburg, Germany
Ev. Krankenhaus Düsseldorf
Düsseldorf, , Germany
Gastroenterologische Praxis
Düsseldorf, , Germany
Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1
Frankfurt, , Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Carola Pflueger
Role: primary
Role: backup
Friedrich Hagenmüller, Prof.Dr.
Role: primary
Horst Neuhaus, Prof. Dr.
Role: primary
Michael Philipper, Dr.
Role: primary
Jörg Albert, PD Dr.
Role: primary
Matthias Bechtler, Dr.
Role: primary
Other Identifiers
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PV3467
Identifier Type: -
Identifier Source: org_study_id