Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-17 @ 8:42 PM
Study NCT ID:
NCT05565469
Status:
UNKNOWN
Last Update Posted:
2022-10-04
First Post:
2022-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-29', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal stimulation', 'timeFrame': 'up to 15 minutes after start of the intervention', 'description': 'Is abdominal wall stimulation present YES/NO and if so what is the score between 0 and 10 on an NRS 1-10. This is then correlated to the position of the electrode.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurostimulator; Complication', 'Neuropathy']}, 'referencesModule': {'references': [{'pmid': '37632515', 'type': 'DERIVED', 'citation': 'Vanloon M, Raymaekers V, Meeuws S, de Ridder D, Plazier M. Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location: A Nonrandomized Clinical Trial. Neuromodulation. 2023 Oct;26(7):1459-1464. doi: 10.1016/j.neurom.2023.07.004. Epub 2023 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a DTM neurostimulator for Failed Back Surgery Syndrome (FBSS) at the thoracic level\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Patients who are not able to exercise their will.\n* Inability to understand the Dutch language'}, 'identificationModule': {'nctId': 'NCT05565469', 'acronym': 'CAWSAN', 'briefTitle': 'Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location', 'orgStudyIdInfo': {'id': 'B2432022000021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurostimulator group', 'description': 'Adjustment of neurostimulator settings to see whether or not abdominal stimulation can be provoked', 'interventionNames': ['Other: Adjustment of neurostimulator settings']}], 'interventions': [{'name': 'Adjustment of neurostimulator settings', 'type': 'OTHER', 'description': 'This is an interventional prospective study. After obtaining informed consent, only necessary information will be extracted through the electronic patient record. Through post-operative imaging, a level determination of the neurostimulator tip will be done. During general consultations, patients will be asked if they experienced abdominal wall stimulation after the procedure and when (YES/NO, NRS). This will include looking at the settings of the neurostimulator. And its adjustments. Furthermore, general epidemiological characteristics such as age, gender, height, weight will be extracted from the electronic patient record.\n\nAt the consultation, another active programming will take place (in accordance with clinical programming) on the tip of the electrode to check whether it provokes abdominal wall stimulation. This will also be scored YES/NO + NRS. Then the settings will be returned as they were pre-consultation.', 'armGroupLabels': ['Neurostimulator group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maarten Vanloon', 'role': 'CONTACT', 'email': 'maarten_vanloon@hotmail.com', 'phone': '+32479545156'}, {'name': 'Mark Plazier, dr.', 'role': 'CONTACT', 'email': 'mark.plazier@jessazh.be'}], 'overallOfficials': [{'name': 'Mark Plazier, dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jessa Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}