Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT06253858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound (US) Guided External Ventricular Catheter Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of time of the procedure', 'timeFrame': 'Up to three hours', 'description': 'Number of minutes necessary to complete the procedure placement of the catheter'}, {'measure': 'Number of revision', 'timeFrame': 'up to 7 days', 'description': 'Quantity of revisions due to the catheter malfunction'}, {'measure': 'Number of subjects with Cerebrospinal fluid (CSF) infection', 'timeFrame': 'up to 7 days', 'description': 'CSF will be collected as part of standard of care after the procedure and tested for infection.'}, {'measure': 'Number of subjects with Superficial surgical site infection (SSI)', 'timeFrame': 'up to 7 days', 'description': '(The CDC defines SSI as deep and superficial. A superficial incisional SSI is an infection in the area of the skin where the incision was made. A deep incisional SSI occurs beneath the incision area in the muscle and the tissues surrounding the muscles. Signs to be monitored daily and put in a checklist will include redness, pain, unexplained fever source, pain, warmth, pus or swelling.)'}, {'measure': 'Longevity of the device function', 'timeFrame': 'up to 7 days', 'description': 'Number of days until a subsequent catheter is placed'}], 'primaryOutcomes': [{'measure': 'Average number of passes needed to place the catheter in each subject.', 'timeFrame': '0 minutes', 'description': 'Measured by the number of passes needed to place the catheter. If the first attempt fails, another US sweep will be performed, and another attempt will be performed. If that fails, then the procedure will be aborted.'}], 'secondaryOutcomes': [{'measure': 'Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system', 'timeFrame': 'up to 7 days', 'description': 'Grade 1 means optimal placement in the ipsilateral frontal horn or third ventricle; Grade 2 means a functional placement in the contralateral lateral ventricle or no eloquent cortex; and Grade 3 means suboptimal placement in the eloquent cortex or nontarget cerebrospinal fluid space, with or without functional drainage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Decision made to perform the procedure by the primary consultant\n* Age 18 or older\n* Neuro ICU stay\n* Newly diagnosed hydrocephalus\n* Has a recent CT within the past 24 hrs\n* Normal platelets and coagulation profile\n* No active infection or currently on antibiotics\n* The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging\n\nExclusion Criteria:\n\n* Age \\<18\n* Not in Neuro ICU setting\n* Previous placement of a ventricular catheter\n* More than 50 percent of the fluid compartment is filled with blood by CT scan\n* Time to include in the trial prohibited by clinical personnel'}, 'identificationModule': {'nctId': 'NCT06253858', 'briefTitle': 'Ultrasound (US) Guided External Ventricular Catheter Placement', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Ultrasound (US) Guided External Ventricular Catheter Placement', 'orgStudyIdInfo': {'id': 'STUDY00022095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Catheter placement with Solopass system', 'description': 'The Solopass US system will be used during catheter placement procedure to guide the placement of the catheter.', 'interventionNames': ['Device: Catheter Placement with Solopass System']}], 'interventions': [{'name': 'Catheter Placement with Solopass System', 'type': 'DEVICE', 'description': 'This device is used as a guidance for placing a brain catheter to target the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.', 'armGroupLabels': ['Catheter placement with Solopass system']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Micaiah Grien', 'role': 'CONTACT', 'email': 'mgrien@pennstatehealth.psu.edu', 'phone': '717-531-0003', 'phoneExt': '283063'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chris Zacko, MD Professor and Vice Chair for Quality, Department of Neurosurgery', 'investigatorFullName': 'Chris Zacko', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}