Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT00013312
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Acute SCI on Colonic Motility & Tone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-01', 'completionDateStruct': {'date': '2001-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2001-03-14', 'studyFirstSubmitQcDate': '2001-03-15', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-03-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Spinal cord injury, gastrointestinal motility, gastrointestinal transit'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Acute SCI with impaired colonic tone'}, 'identificationModule': {'nctId': 'NCT00013312', 'briefTitle': 'Effects of Acute SCI on Colonic Motility & Tone', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Effects of Acute SCI on Colonic Motility & Tone', 'orgStudyIdInfo': {'id': 'B1862R'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Determine colonic tone', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'VAMC, Hines', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}], 'overallOfficials': [{'name': 'John Fryer, Ph.D. Asst. Director', 'affiliation': 'Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service'}, {'name': 'Nancy Rocheleau, Program Analyst', 'affiliation': 'Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}}}}