Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-19 @ 11:36 PM
Study NCT ID:
NCT02805959
Status:
UNKNOWN
Last Update Posted:
2016-06-21
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-06-19', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transit time through the small intestine and the colon. Both the total transit time, the regional transit times and the antegrade and retrograde movements are measured by the MTS system', 'timeFrame': 'The total transit time will differ between healthy and constipated but probably between 3-5 days.', 'description': 'The measurements will all be at least three days long, but can be up to 5 days depending on the rate of bowel movements.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with constipation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Constipation\n\nExclusion Criteria:\n\n* Constipation caused by other disease'}, 'identificationModule': {'nctId': 'NCT02805959', 'briefTitle': 'Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Colonic Motility in Constipation and Aging: A Pilot Study With a New 3D Transit System', 'orgStudyIdInfo': {'id': 'Fynne'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Constipated, Elderly', 'description': 'Investigation with MTS for motility', 'interventionNames': ['Device: MTS2']}, {'label': 'Constipation, Young', 'description': 'Investigation with MTS for motility', 'interventionNames': ['Device: MTS2']}, {'label': 'Normal Bowel, Elderly', 'description': 'Investigation with MTS for motility', 'interventionNames': ['Device: MTS2']}, {'label': 'Normal Bowel, Young', 'description': 'Investigation with MTS for motility', 'interventionNames': ['Device: MTS2']}], 'interventions': [{'name': 'MTS2', 'type': 'DEVICE', 'armGroupLabels': ['Constipated, Elderly', 'Constipation, Young', 'Normal Bowel, Elderly', 'Normal Bowel, Young']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}