Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT04883060
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Testing for Midline Measuring Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthew-howard@uiowa.edu', 'phone': '(319) 356-8468', 'title': 'Matthew Howard III', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the start of surgery until surgical closure, up to 2.5 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Patients undergoing ventriculoperitoneal surgery where the midline localizer was used\n\nmidline localizer: a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Incorrect Burr Hole Placement', 'notes': 'Burr hole was not between 3 and 4 cm away from anatomical midline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricle Catheter Misplacement', 'notes': 'Catheter tip entered the parenchyma at the level of gyrus fasciolaris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Midline Localization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing ventriculoperitoneal surgery where the midline localizer was used\n\nmidline localizer: a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediate postop, an average of 4 hours', 'description': 'The average distance separating the staple from the lateral edge of the sagittal sinus', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Burr Hole Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing ventriculoperitoneal surgery where the midline localizer was used\n\nmidline localizer: a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately Post-op, an average of 4 hours', 'description': 'Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Patients undergoing ventriculoperitoneal surgery where the midline localizer was used\n\nmidline localizer: a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Patients undergoing ventriculoperitoneal surgery where the midline localizer was used\n\nmidline localizer: a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-10', 'size': 117823, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-10T11:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2021-05-06', 'resultsFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-04', 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Midline Localization', 'timeFrame': 'Immediate postop, an average of 4 hours', 'description': 'The average distance separating the staple from the lateral edge of the sagittal sinus'}], 'secondaryOutcomes': [{'measure': 'Burr Hole Placement', 'timeFrame': 'Immediately Post-op, an average of 4 hours', 'description': 'Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventriculo-Peritoneal Shunt Infection']}, 'descriptionModule': {'briefSummary': "Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery\n\nExclusion Criteria:\n\n* Patients who are not able to consent'}, 'identificationModule': {'nctId': 'NCT04883060', 'acronym': 'MMD', 'briefTitle': 'Pilot Testing for Midline Measuring Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Pilot Testing for Midline Measuring Device', 'orgStudyIdInfo': {'id': '201704798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients undergoing ventriculoperitoneal surgery where the midline localizer was used', 'interventionNames': ['Device: midline localizer']}], 'interventions': [{'name': 'midline localizer', 'type': 'DEVICE', 'description': 'a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Univeristy of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurosurgery, Head of Department of Neurosurgery at University of Iowa', 'investigatorFullName': 'Matthew Howard', 'investigatorAffiliation': 'University of Iowa'}}}}