Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-24 @ 5:21 PM
Study NCT ID:
NCT01480635
Status:
UNKNOWN
Last Update Posted:
2011-11-29
First Post:
2011-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy', 'timeFrame': 'One week follow up', 'description': 'Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Incomplete Colonoscopy', 'Efficacy of PillCam Colon2'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'Purpose of study:\n\nTo evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy\n\nStudy design: 4 centers, prospective, cohort study Number of subjects: 74 subjects\n\nSubject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy\n\nControl group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months\n\nPrimary 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is \\>/= 18 years\n* Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.\n* 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\n\nExclusion Criteria:\n\n* Subject has dysphagia or any swallowing disorder\n* Subject has severe congestive heart failure or renal insufficiency\n* Subject with high risk for capsule retention\n* Subject has a cardiac pacemakers or other implanted electromedical devices\n* Subject has any allergy or other contraindication to the medications used in the study\n* 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.\n* 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\n* Subject suffers from life threatening conditions\n* Subject currently participating in another clinical study\n* Colonoscopy had been performed by a physician who has experience of \\<1000 complete colonoscopies\n* Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope\n* Time interval between incomplete colonoscopy and capsule endoscopy \\>30 days'}, 'identificationModule': {'nctId': 'NCT01480635', 'acronym': 'PCCE', 'briefTitle': 'PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Bethesda Krankenhaus'}, 'officialTitle': 'Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy', 'orgStudyIdInfo': {'id': 'PV3467'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Incomplete Colonoscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21029', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Carola Pflueger', 'role': 'CONTACT', 'email': 'pflueger@bkb.info', 'phone': '+49-40-72554', 'phoneExt': '1617'}, {'role': 'CONTACT', 'phone': '+49-40-72554', 'phoneExt': '1201'}, {'name': 'Martin Keuchel, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bethesda Krankenhaus Bergedorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22763', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Friedrich Hagenmüller, Prof.Dr.', 'role': 'CONTACT', 'email': 'f.hagenmüller@asklepios.com', 'phone': '+49-40-181881', 'phoneExt': '8314'}, {'name': 'Friedrich Hagenmüller, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Klinik Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '40217', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Horst Neuhaus, Prof. Dr.', 'role': 'CONTACT', 'email': 'horst.neuhaus@evk-duesseldorf.de', 'phone': '+49-211-919', 'phoneExt': '1605'}, {'name': 'Horst Neuhaus, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ev. Krankenhaus Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40227', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Philipper, Dr.', 'role': 'CONTACT', 'email': 'miphi@ish.de', 'phone': '+49-0211-773024'}, {'name': 'Michael Philipper, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gastroenterologische Praxis', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60590', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Albert, PD Dr.', 'role': 'CONTACT', 'email': 'J.Albert@med.uni-frankfurt.de', 'phone': '+49-69-6301', 'phoneExt': '5297'}, {'name': 'Jörg Albert, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '67063', 'city': 'Ludwigshafen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Bechtler, Dr.', 'role': 'CONTACT', 'phone': '+49-06215030'}, {'name': 'Ralf Jakobs, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum der Stadt Ludwigshafen am Rhein', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}], 'centralContacts': [{'name': 'Martin Keuchel, Dr.', 'role': 'CONTACT', 'email': 'keuchel@bkb.info', 'phone': '+49-40-72554', 'phoneExt': '1201'}, {'name': 'Peter Baltes, Dr.', 'role': 'CONTACT', 'email': 'baltes@bkb.info', 'phone': '+49-40-72554', 'phoneExt': '2198'}], 'overallOfficials': [{'name': 'Martin Keuchel, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bethesda Krankenhaus Bergedorf, Hamburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bethesda Krankenhaus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}