Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-01 @ 3:27 AM
Study NCT ID:
NCT05015933
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2021-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Pump Refills at Home
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': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2021-08-14', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.'}, {'measure': 'Successful pump refill', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'A binary variable to indicate success or failure of this intervention, reported by the physician.'}, {'measure': 'Patient safety', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.'}, {'measure': 'Physician safety', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.'}], 'secondaryOutcomes': [{'measure': 'Environmental safety', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'An open question in which the physician can indicate whether there were any situations that were not safe.'}, {'measure': 'Clean, sterile procedure', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'An open question in which the physician can mention all potential risks.'}, {'measure': 'An objective confirmation of correct injection in the pump by ultrasound.', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'After the refill procedure is performed, an ultrasound will be made to visually ensure that the refill was correctly performed without loss of liquor outside the pump.'}, {'measure': 'Adverse events', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'All adverse events will systematically be reported by the physician.'}, {'measure': 'Patient feasibility', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.'}, {'measure': 'Quality of teleconsultant connection by teleconsultant', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'Quality of the internet connection will be evaluated by the teleconsultant.'}, {'measure': 'Time burden for teleconsultant', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'The time will be measured from the beginning until the end of the call.'}, {'measure': 'Physician feasibility', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.'}, {'measure': 'Quality of teleconsultant connection by physician', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'Quality of the internet connection will be evaluated by the physician.'}, {'measure': 'Time burden for physician', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'The time will be measured from the beginning until the end of the call.'}, {'measure': 'Patient preference', 'timeFrame': 'Once, at the moment of the study visit, immediately after the pump refill', 'description': 'Patients will be asked to indicate whether they prefer to have their next refill at home.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrathecal Drug Delivery', 'Implantable Pump', 'Telemedicine']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient receives intrathecal drug therapy\n* Patient is at least 18 years old\n* Native French-or Dutch speaking persons.\n\nExclusion Criteria:\n\n* Patients \\< 18 years old.\n* No native Dutch or French speaking persons.'}, 'identificationModule': {'nctId': 'NCT05015933', 'briefTitle': 'Intrathecal Pump Refills at Home', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.', 'orgStudyIdInfo': {'id': 'ESCAPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Refill at home', 'description': 'Patients will have one pump refill at home instead of at the hospital.', 'interventionNames': ['Procedure: Pump refill procedure at home']}], 'interventions': [{'name': 'Pump refill procedure at home', 'type': 'PROCEDURE', 'description': 'Implantable pump refill is performed at home', 'armGroupLabels': ['Refill at home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moens Maarten', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Moens Maarten', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}