Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:08 AM
Study NCT ID:
NCT07384559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To obtain usable MRI 3D images of lower urinary tract and surroundings during voiding (healthy subjects) and during bladder emptying with IC (healthy subjects and SCI subjects).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).', 'timeFrame': 'up to 28 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retention, Urinary']}, 'descriptionModule': {'briefSummary': 'This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has given written informed consent\n2. Is at least 18 years old\n3. Has full legal capacity\n4. Is able (assessed by investigator) and willing to adhere to study procedures during study duration\n5. Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes\\*\n6. Known with SCI for a minimum of 1 year\\*\n7. Has used IC as primary bladder emptying method for at least 3 months\\* \\* Only for SCI subjects\n\nExclusion Criteria:\n\n1. Is participating in any other clinical investigation during this investigation\n2. Has previously completed this investigation\n3. Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation\n4. Is pregnant\n5. Has had surgical procedures performed in the lower urinary tract.\n6. Has active/recurrent bladder cancer\n7. Has experienced autonomic dysreflexia within the last 2 years\n8. Has any MRI-scanning contraindications, according to MR check list provided by the site (e.g. active implants like pacemaker, cochlear implant, event recorder, implanted insulin pump)\n9. Has symptoms of UTI at times of inclusion, as judged by the investigator.\n10. Has a body weight that exceeds the maximum of 150kg max'}, 'identificationModule': {'nctId': 'NCT07384559', 'briefTitle': 'Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner', 'orgStudyIdInfo': {'id': 'CP386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI scan', 'description': 'MRI scan of SCI and healthy male/female subjects during catheterization', 'interventionNames': ['Other: MRI scan']}], 'interventions': [{'name': 'MRI scan', 'type': 'OTHER', 'description': 'MRI scan of SCI and healthy male/female subjects during catheterization', 'armGroupLabels': ['MRI scan']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karen Grigo, PhD', 'role': 'CONTACT', 'email': 'DEKAGR@coloplast.com', 'phone': '+49 17 28 49 34 17'}], 'overallOfficials': [{'name': 'Walter Wigger-Alberti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurofins bioskin GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}