Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT04624334
Status:
TERMINATED
Last Update Posted:
2022-05-19
First Post:
2020-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Assessment of Colonic Motility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D006627', 'term': 'Hirschsprung Disease'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D008531', 'term': 'Megacolon'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Money issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-12', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Power Percent Difference', 'timeFrame': 'During EEnG procedure', 'description': 'Relative power change when comparing pre-prandial EEnG measurements to post-prandial measurements. Power will be calculated as the mean amplitude (mV\\^2/Hz) in a bandwidth of 2 cycles per minute around the dominant frequency related to colonic movements (between 2-10 cycles per minute).'}], 'secondaryOutcomes': [{'measure': 'EEnG questionnaire score', 'timeFrame': 'Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo', 'description': 'Burden score of EEnG procedure as assessed by a self created questionnaire (in collaboration with medical doctors, a psychologist and representatives of the patients association). A mean score of 0 indicates maximum burden, a mean score of 10 means no burden at all.'}, {'measure': 'Gold Standard questionnaire score', 'timeFrame': 'Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo, or directly after the gold standard procedure, which some subjects will undergo in the near future at time of inclusion', 'description': 'Total burden score of Gold Standard procedure used to diagnose motility disorder as assessed by a self created questionnaire (in collaboration with medical doctors, a psychologist and representatives of the patients association). A mean score of 0 indicates maximum burden, a mean score of 10 means no burden at all.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Disease', 'Functional Constipation', 'Electroenterography', 'Slow Transit', 'Hirschsprung Disease']}, 'descriptionModule': {'briefSummary': "The current diagnostic process of colonic motility disorders often takes a long time and involves multiple invasive, painful and/or unnecessary diagnostic procedures. To improve this diagnostic process, the potential of Electro-Entero-Graphy (EEnG) is investigated.\n\nDuring the EEnG procedure, several surface electrodes are positioned (under ultrasound guidance) on the abdomen so that electrical activity originating in the colon can be measured. Measurements will be performed after a period of fasting (when the colon is 'silent') and just after a meal (when the colon is moving) in both participants suffering from colonic motility disorders and healthy controls.\n\nIt is hypothesized that these measurements are an indication of colonic motility and can be used as a diagnostic tool for colonic motility disorders. It is also hypothesized that this EEnG procedure is not more burdensome than the Gold Standard procedures for diagnosing colonic motility disorders. This will be assessed using questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All subjects fulfilling the in- and exclusion criteria will be included. Participants with (suspected) motility disorder will be recruited mainly in the Radboudumc and with the help from the Hirschsprung's patient association.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants:\n* Age ≤ 11 years for babies and children\n* Age ≥ 18 years for adults.\n\nPatients\n\n* For babies/children:\n\n * suffering from surgically untreated HSCR as determined by a rectal biopsy, or\n * suspected of HSCR, for which a rectal biopsy is planned\n* For adults: Suffering from a (suspected,) surgically untreated functional colonic motility disorder (such as slow-transit constipation, idiopathic/therapy resistant constipation of the colon), as diagnosed previously or will be diagnosed in the near future using the gold standard method.\n\nExclusion criteria:\n\n* All participants:\n* For adults: BMI \\> 27 kg/m2\n* For babies/children: weight for length \\> 2.5 standard deviations of WHO Child Growth Standard\n* Pregnancy\n* Diabetes\n* Any food intolerance\n* Presence of an intestinal stoma\n* Use of continuous tube feeding\n* Healthy controls:\n* The presence of any known gastro-intestinal conditions\n* Use of laxatives in the past two years\n* Participants with (suspected) motility disorder:\n* (Part of) colon removed\n* Inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT04624334', 'acronym': 'non-CoMoti', 'briefTitle': 'Non-invasive Assessment of Colonic Motility', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel', 'orgStudyIdInfo': {'id': '110933'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with motility disorder', 'interventionNames': ['Other: Elektro-Entero-Graphy procedure', 'Other: EEnG Questionnaire', 'Other: Gold Standard Questionnaire']}, {'label': 'Healthy children', 'interventionNames': ['Other: Elektro-Entero-Graphy procedure', 'Other: EEnG Questionnaire']}, {'label': 'Adults with motility disorder', 'interventionNames': ['Other: Elektro-Entero-Graphy procedure', 'Other: EEnG Questionnaire', 'Other: Gold Standard Questionnaire']}, {'label': 'Healthy adults', 'interventionNames': ['Other: Elektro-Entero-Graphy procedure', 'Other: EEnG Questionnaire']}], 'interventions': [{'name': 'Elektro-Entero-Graphy procedure', 'type': 'OTHER', 'description': 'Fasting, after which pre- and postprandial EEnG measurements are performed.', 'armGroupLabels': ['Adults with motility disorder', 'Children with motility disorder', 'Healthy adults', 'Healthy children']}, {'name': 'EEnG Questionnaire', 'type': 'OTHER', 'description': 'Filling out questionnaire about EEnG procedure.', 'armGroupLabels': ['Adults with motility disorder', 'Children with motility disorder', 'Healthy adults', 'Healthy children']}, {'name': 'Gold Standard Questionnaire', 'type': 'OTHER', 'description': 'Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.', 'armGroupLabels': ['Adults with motility disorder', 'Children with motility disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'S.M.B.I. Botden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication of the results.', 'ipdSharing': 'YES', 'description': 'IPD will be available to other researchers on reasonable request.', 'accessCriteria': 'Upon reasonable request via e-mail.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}