Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT03533894
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2018-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Observational Study With Colic Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 680}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-11', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2018-05-11', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of polyps or lesions', 'timeFrame': '5 years', 'description': 'number of polyps or lesions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colic Capsule Interest']}, 'descriptionModule': {'briefSummary': 'colic capsule usings with patients without possible colic endoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men or women with colic endoscopy problems', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anesthesia not possible\n* incomplete colic endoscopy\n* colic endoscopy refused\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03533894', 'briefTitle': 'French Observational Study With Colic Capsule', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'officialTitle': 'French Observational Study With Colic Capsule', 'orgStudyIdInfo': {'id': 'ONECC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'colic capsule', 'type': 'DEVICE', 'description': 'colic polyp diagnosis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean Christophe Saurin', 'investigatorAffiliation': 'Hôpital Edouard Herriot'}}}}