Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT01752361
Status:
UNKNOWN
Last Update Posted:
2014-01-07
First Post:
2012-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Velocity of progression through the small intestine in severe UC compared to velocity of progression through the small intestine in healthy volunteers.', 'timeFrame': 'three days from baseline visit'}], 'primaryOutcomes': [{'measure': 'Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in healthy volunteers.', 'timeFrame': 'Three days from baseline visit'}], 'secondaryOutcomes': [{'measure': 'Velocity of progression through the non-inflamed colonic segments in severe UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.', 'timeFrame': 'Three days from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastrointestinal Motility', 'Inflammatory Bowel Disease', 'Transit time'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results from a study on healthy subjects.\n\nBoth studies are done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.\n\nThe study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe inflammation.\n\nMotilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a whole during severe illness.\n\nWe expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. We do not expect any drop out, but in case of drop out a new patient will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from severe Ulcerative Colitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe Ulcerative colitis (modified Truelove and Witt score)\n* Signed informed consent obtained\n* Fasted since midnight\n\nExclusion Criteria:\n\n* Known GI related symptoms complaints or GI diseases\n* Swallowing disorders\n* Cancer or other life threatening diseases or conditions\n* Pregnancy or breast-feeding\n* Previous abdominal surgery\n* Abdominal diameter \\>140cm?\n* Drug abuse or alcoholism\n* Irregular bowel movements\n* Known cardiovascular or pulmonary diseases\n* Participation in any clinical study within the last 30 days\n* Cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.\n* Medication affecting GI motility\n* MRI within the next four weeks'}, 'identificationModule': {'nctId': 'NCT01752361', 'briefTitle': 'Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Gastrointestinal Transit Times and Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit', 'orgStudyIdInfo': {'id': 'M-20110276'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ulcerative Colitis', 'interventionNames': ['Device: Motilis-3D transit']}], 'interventions': [{'name': 'Motilis-3D transit', 'type': 'DEVICE', 'armGroupLabels': ['Ulcerative Colitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'AnneMette Haase, Ph.d Student', 'role': 'CONTACT', 'email': 'annemette.haase@ki.au.dk', 'phone': '+45 6165 8483'}, {'name': 'AnneMette Haase, Ph.d Student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital, Department of Hepato and Gastroenterolegy', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'centralContacts': [{'name': 'AnneMette Haase, Ph.d Student', 'role': 'CONTACT', 'email': 'annemette.haase@au.ki.dk', 'phone': '+45 6165 8483'}, {'name': 'Klaus Krogh, Professor', 'role': 'CONTACT', 'email': 'klaukrog@rm.dk', 'phone': '+45 2338 5937'}], 'overallOfficials': [{'name': 'AnneMette Haase, Ph.d Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Motilis Medica A/S ,Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}