Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02382705
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2015-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SB3 Battery Life Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cgalorport@gmail.com', 'phone': '604 688 6332', 'title': 'Dr. Robert Enns', 'organization': 'University of British Columbia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PillCam SB3EX', 'description': 'Patients who were eligible to participate in the study were recruited and enrolled. Enrolled participants were given instructions for capsule endoscopy as per standard of practice at our institution. External sensors and data recorder for use with the PillCam capsule were placed. Patients swallowed the capsule. All capsule endoscopy were allowed to run/record until the recording terminates due to battery outage (usually after 12 h) or passage of CE out of the gastrointestinal tract, as indicated by cessation of flashing light on the recorder. External sensors and data recorder were removed at the end of the recording and patients returned the equipment to the institution the next day.', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Completion Rate (Rate at Which Small Bowel is Completely Examined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PillCam SB3EX'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0.1 - 12 hours', 'description': 'rate at which small bowel is completely examined (capsule endoscopy enters cecum)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnostic Yield', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PillCam SB3EX'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0.1 - 12 hours', 'description': 'rate at which a pathological finding is identified on capsule endoscopy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastric Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PillCam SB3EX'}], 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '92.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.1 - 12 hours', 'description': 'time it takes for capsule camera to traverse the stomach', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Small Bowel Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PillCam SB3EX'}], 'classes': [{'categories': [{'measurements': [{'value': '232.1', 'spread': '98.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.1 - 12 hours', 'description': 'times it takes for capsule camera to traverse the entire small bowel.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PillCam SB3EX', 'description': 'All participants in the study used the PillCam SB3EX for their capsule endoscopy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PillCam SB3EX', 'description': 'All participants in the study used the PillCam SB3EX for their capsule endoscopy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '15.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-24', 'studyFirstSubmitDate': '2015-03-03', 'resultsFirstSubmitDate': '2018-12-24', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-24', 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion Rate (Rate at Which Small Bowel is Completely Examined)', 'timeFrame': '0.1 - 12 hours', 'description': 'rate at which small bowel is completely examined (capsule endoscopy enters cecum)'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Yield', 'timeFrame': '0.1 - 12 hours', 'description': 'rate at which a pathological finding is identified on capsule endoscopy'}, {'measure': 'Gastric Transit Time', 'timeFrame': '0.1 - 12 hours', 'description': 'time it takes for capsule camera to traverse the stomach'}, {'measure': 'Small Bowel Transit Time', 'timeFrame': '0.1 - 12 hours', 'description': 'times it takes for capsule camera to traverse the entire small bowel.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['capsule endoscopy', 'battery life', 'completion rate', 'diagnostic yield'], 'conditions': ['Capsule Endoscopy']}, 'descriptionModule': {'briefSummary': "Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.\n\nWhile CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended.\n\nThis study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing small bowel capsule endoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 19 or greater who are referred for small bowel capsule endoscopy\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Unwillingness or inability to swallow pill\n* Known or suspected obstruction or bowel stricture\n* Endoscopic placement of capsule camera\n* Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)'}, 'identificationModule': {'nctId': 'NCT02382705', 'briefTitle': 'SB3 Battery Life Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Clinical Impact of Longer Battery Life on Small Bowel Capsule Endoscopy: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'H14-03253'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 2K5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Robert Enns, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Robert Enns', 'investigatorAffiliation': 'University of British Columbia'}}}}