Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-04-13 @ 10:17 PM
Study NCT ID:
NCT02182466
Status:
TERMINATED
Last Update Posted:
2017-12-15
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
German Colon Capsule Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishing a diagnosis from colon capsule endoscopy', 'timeFrame': 'At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation', 'description': 'Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay, an expected average of 2 weeks after performance of the investigation'}], 'secondaryOutcomes': [{'measure': 'Technical success of colon capsule endoscopy', 'timeFrame': 'At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours', 'description': 'Technical success is evaluated during the investigation and immediately after to identifal correct technical function of the capsule endoscope including technical performance of the system, battery life of the capsule, passage of colon capsule, review of the capsule video, and documentation'}, {'measure': 'Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events', 'timeFrame': 'At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation', 'description': 'Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay. Thereby, participants with adverse events attributable to colon capsule endoscopy are assessed and AE characterized.'}, {'measure': 'Cleansing level of colon capsule endoscopy', 'timeFrame': 'At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation', 'description': 'Cleansing level of the colon is assessed and qualified as adequate or as not adequate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colon capsule endoscopy', 'Colonoscopy', 'Screening colonoscopy'], 'conditions': ['Colon Cancer', 'Colon Polyp', 'Diarrhea', 'Inflammatory Bowel System', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.', 'detailedDescription': 'Colon capsule endoscopy (CCE, Pill Cam Colon 2, (Given Imaging Ltd, Yoqneam, Israel and Given Imaging EMEA, Hamburg, Germany) provides direct visualization of the colon mucosa, enabling the investigator to diagnose colonic disease. CCE is a complementary means to flexible ileo-colonoscopy andt safety, quality assurance and quality control of CCE is not well understood. There are about 15 000 investigations performed worldwide until now, but systematic data on performance in a community based setting are lacking.\n\nThis study aims to investigate safety, quality assurance and quality control of colon capsule endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with indication for endoscopic investigation of the colon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for colon capsule endoscopy\n* Age of 18 years or older\n* Consent of the patient\n\nExclusion Criteria:\n\n* Intestinal obstruction\n* Dyphagia\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02182466', 'acronym': 'DEKOR', 'briefTitle': 'German Colon Capsule Registry', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]', 'orgStudyIdInfo': {'id': '265/13'}, 'secondaryIdInfos': [{'id': 'DRKS-ID: DRKS00006283', 'type': 'OTHER', 'domain': 'German Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colonic endoscopy indicated', 'interventionNames': ['Device: Colon capsule endoscopy']}], 'interventions': [{'name': 'Colon capsule endoscopy', 'type': 'DEVICE', 'armGroupLabels': ['Colonic endoscopy indicated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Frankfurt University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Jörg G Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '[Dokumentation von Kolonkapsel-Endoskopien im Rahmen einer bundesweiten Studie]', 'investigatorFullName': 'Jorg Albert', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}