Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-03 @ 9:38 PM
Study NCT ID:
NCT01885468
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
X-Ray Verified Accuracy of the proGAV Verification Instrument
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.', 'timeFrame': '1day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydrocephalus shunt', 'proGAV'], 'conditions': ['Hydrocephalus Shunt (proGAV) Requiring Adjustment']}, 'descriptionModule': {'briefSummary': "This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hydrocephalus patients implanted with proGAV shunt requiring adjustment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implanted with proGAV Requiring adjustment Implant must be palpable under the skin\n\nExclusion Criteria:\n\n* Unwilling to consent Implanted within 7 days of inclusion visit'}, 'identificationModule': {'nctId': 'NCT01885468', 'acronym': 'X-AMIN', 'briefTitle': 'X-Ray Verified Accuracy of the proGAV Verification Instrument', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap, Inc.'}, 'officialTitle': 'X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument', 'orgStudyIdInfo': {'id': 'AAG-G-H-1106'}}, 'contactsLocationsModule': {'locations': [{'zip': '93636-8762', 'city': 'Madeira', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Hospital"}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}