PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
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Purpose
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
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy |
- Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy [ Time Frame: One week follow up ] [ Designated as safety issue: Yes ]Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.
| Estimated Enrollment: | 74 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Incomplete Colonoscopy |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Contact: Martin Keuchel, Dr. | +49-40-72554 ext 1201 | keuchel@bkb.info |
| Contact: Peter Baltes, Dr. | +49-40-72554 ext 2198 | baltes@bkb.info |
| Germany | |
| Ev. Krankenhaus Düsseldorf | Recruiting |
| Düsseldorf, Germany, 40217 | |
| Contact: Horst Neuhaus, Prof. Dr. +49-211-919 ext 1605 horst.neuhaus@evk-duesseldorf.de | |
| Principal Investigator: Horst Neuhaus, Prof. Dr. | |
| Gastroenterologische Praxis | Recruiting |
| Düsseldorf, Germany, 40227 | |
| Contact: Michael Philipper, Dr. +49-0211-773024 miphi@ish.de | |
| Principal Investigator: Michael Philipper, Dr. | |
| Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1 | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Jörg Albert, PD Dr. +49-69-6301 ext 5297 J.Albert@med.uni-frankfurt.de | |
| Principal Investigator: Jörg Albert, PD Dr. | |
| Asklepios Klinik Altona | Recruiting |
| Hamburg, Germany, 22763 | |
| Contact: Friedrich Hagenmüller, Prof.Dr. +49-40-181881 ext 8314 f.hagenmüller@asklepios.com | |
| Principal Investigator: Friedrich Hagenmüller, Prof. Dr. | |
| Bethesda Krankenhaus Bergedorf | Recruiting |
| Hamburg, Germany, 21029 | |
| Contact: Carola Pflueger +49-40-72554 ext 1617 pflueger@bkb.info | |
| Contact +49-40-72554 ext 1201 | |
| Principal Investigator: Martin Keuchel, Dr. | |
| Klinikum der Stadt Ludwigshafen am Rhein | Recruiting |
| Ludwigshafen, Germany, 67063 | |
| Contact: Matthias Bechtler, Dr. +49-06215030 | |
| Principal Investigator: Ralf Jakobs, Prof. Dr. | |
| Principal Investigator: | Martin Keuchel, Dr. | Bethesda Krankenhaus Bergedorf, Hamburg, Germany |
More Information
No publications provided
| Responsible Party: | Bethesda Krankenhaus |
| ClinicalTrials.gov Identifier: | NCT01480635 History of Changes |
| Other Study ID Numbers: | PV3467 |
| Study First Received: | October 13, 2011 |
| Last Updated: | November 28, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bethesda Krankenhaus:
|
Incomplete Colonoscopy Efficacy of PillCam Colon2 |
ClinicalTrials.gov processed this record on May 23, 2013