Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT01360502
Status:
COMPLETED
Last Update Posted:
2011-05-25
First Post:
2011-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-24', 'studyFirstSubmitDate': '2011-05-23', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['capsule endoscopy', 'cardiac pacemaker', 'implantable cardiac defibrillator'], 'conditions': ['Gastrointestinal Disease', 'Anemia']}, 'descriptionModule': {'briefSummary': 'This is a prospective study designed to assess safety and potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.', 'detailedDescription': 'MiroCam (IntroMedic, Ltd, Seoul, Korea) is a small bowel capsule endoscope using human body communication for data transmission. There is a concern of potential interactions between cardiac devices and capsule endoscope. This clinical study was designed to evaluate the potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with implantable cardiac devices', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age 20 years or older\n2. cardiac pacemaker or implantable cardiac defibrillator\n3. gastrointestinal disease\n\nExclusion Criteria:\n\n1. previous GI perforation or obstruction history\n2. known or suspected GI stricture\n3. marked GI dysmotility\n4. uncompensated heart failure (EF ≤30% or Killip's classification class ≥ III)\n5. pregnancy"}, 'identificationModule': {'nctId': 'NCT01360502', 'briefTitle': 'Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Safety of Capsule Endoscopy Using Human Body Communication in Patients With Cardiac Pacemakers and Implantable Cardiac Defibrillators', 'orgStudyIdInfo': {'id': '1-2009-0021'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Si Young Song, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Si Young Song', 'oldOrganization': 'Yonsei University College of Medicine'}}}}