Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:17 AM
Study NCT ID:
NCT07467720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.', 'timeFrame': 'Intraprocedural', 'description': 'The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. The two methods being compared are traditional lead aprons and shields and the RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.'}], 'secondaryOutcomes': [{'measure': 'The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.', 'timeFrame': 'Intraprocedural', 'description': 'The secondary endpoint will be to compare radiation exposure on a per body segment analysis on the care team using a Raysafe i3 dosimeter badge. The investigators will compare traditional lead aprons and ancillary shields to the RAMPART IC System with optional lead aprons.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Radiation Protection']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Catheter Cardiovasc Interv. 2009;73(3): 432-438. https://doi.org/10.1002/ccd.21801'}, {'type': 'BACKGROUND', 'citation': 'Occ Med. 2010;60(6):464-9'}, {'type': 'BACKGROUND', 'citation': 'Circulation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273'}]}, 'descriptionModule': {'briefSummary': 'Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial', 'detailedDescription': 'An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Member of the interventional care team\n* Elective peripheral procedure\n* The access site is the femoral artery\n* The treatment area is at or distal to the iliac artery\n\nExclusion Criteria:\n\n* Individuals who are not yet adults, pregnant women, or prisoners.\n* Urgent and emergent cases'}, 'identificationModule': {'nctId': 'NCT07467720', 'acronym': 'SECURE', 'briefTitle': 'Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial', 'orgStudyIdInfo': {'id': '026-232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional Lead Apron and Shields', 'description': 'These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rampart IC System', 'description': 'The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.', 'interventionNames': ['Device: Rampart IC System']}], 'interventions': [{'name': 'Rampart IC System', 'type': 'DEVICE', 'description': 'RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases.', 'armGroupLabels': ['Rampart IC System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Bonnie Ostergren', 'role': 'CONTACT', 'email': 'bonnie.ostergren@bswhealth.org', 'phone': '469-814-4181'}], 'facility': 'Baylor Scott & White The Heart Hospital- Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'centralContacts': [{'name': 'Bonnie Ostergren', 'role': 'CONTACT', 'email': 'bonnie.ostergren@bswhealth.org', 'phone': '469-814-4181'}, {'name': 'Sarah Hale', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}