PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
Study Details
Study Description
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
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Incomplete Colonoscopy
|
Outcome Measures
Primary Outcome Measures
- Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy [One week follow up]
Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is >/= 18 years
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Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
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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:
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Subject has dysphagia or any swallowing disorder
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Subject has severe congestive heart failure or renal insufficiency
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Subject with high risk for capsule retention
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Subject has a cardiac pacemakers or other implanted electromedical devices
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Subject has any allergy or other contraindication to the medications used in the study
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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.
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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
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Subject suffers from life threatening conditions
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Subject currently participating in another clinical study
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Colonoscopy had been performed by a physician who has experience of <1000 complete colonoscopies
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Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
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Time interval between incomplete colonoscopy and capsule endoscopy >30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ev. Krankenhaus Düsseldorf | Düsseldorf | Germany | 40217 | |
| 2 | Gastroenterologische Praxis | Düsseldorf | Germany | 40227 | |
| 3 | Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1 | Frankfurt | Germany | 60590 | |
| 4 | Bethesda Krankenhaus Bergedorf | Hamburg | Germany | 21029 | |
| 5 | Asklepios Klinik Altona | Hamburg | Germany | 22763 | |
| 6 | Klinikum der Stadt Ludwigshafen am Rhein | Ludwigshafen | Germany | 67063 |
Sponsors and Collaborators
- Bethesda Krankenhaus
- Medtronic - MITG
Investigators
- Principal Investigator: Martin Keuchel, Dr., Bethesda Krankenhaus Bergedorf, Hamburg, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PV3467