Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-28 @ 6:11 AM
Study NCT ID:
NCT05730959
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-02-16
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacral Nerve Modulation in IPAA Patients With Poor Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Øresland Score', 'timeFrame': '12 months', 'description': 'functional score'}], 'secondaryOutcomes': [{'measure': 'Bowel physiology', 'timeFrame': 'At inclusion and at 12 months', 'description': 'Barostat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IPAA (Ileal Pouch-Anal Anastomosis)', 'SNM (Sacral Nerve Modultion)'], 'conditions': ['Stoma Malfunction']}, 'descriptionModule': {'briefSummary': 'IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* UC With IPAA\n* Bad functional outcome\n\nExclusion Criteria:\n\n* Established treatable cause of malfunction'}, 'identificationModule': {'nctId': 'NCT05730959', 'briefTitle': 'Sacral Nerve Modulation in IPAA Patients With Poor Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Sacral Nerve Modulation in IPAA Patients With Poor Function', 'orgStudyIdInfo': {'id': '2014/2206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'malfunctioning IPAA', 'description': 'Patients with malfunctioning IPAA', 'interventionNames': ['Device: Sacral nerve modulation']}], 'interventions': [{'name': 'Sacral nerve modulation', 'type': 'DEVICE', 'description': 'Implant of nerve stimulator', 'armGroupLabels': ['malfunctioning IPAA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tom Oresland, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Tom Oresland', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}