Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-02 @ 6:08 AM
Study NCT ID:
NCT04950959
Status:
RECRUITING
Last Update Posted:
2022-10-21
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XACT ACE Observational Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of successful procedures', 'timeFrame': '1 hour', 'description': "To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation."}, {'measure': 'System accuracy', 'timeFrame': '1 hour', 'description': 'To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.'}, {'measure': 'Assessment of Safety', 'timeFrame': '2 hours post-procedure', 'description': 'Incidence of intra- and post-procedural events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT-guided percutaneous procedure', 'Percutaneous biopsy', 'XACT ACE Robotic System'], 'conditions': ['Tumors']}, 'descriptionModule': {'briefSummary': 'Compile real world data on the use of the XACT ACE Robotic System', 'detailedDescription': "The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.\n\nThe objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.\n\nUp to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing CT guided, minimally invasive percutaneous procedures in an interventional radiology setting.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite\n3. Subject is willing to sign informed consent for the purposes of data collection\n\nExclusion Criteria:\n\n1\\. No exclusion criteria other than listed in the product Instructions for Use (IFU)'}, 'identificationModule': {'nctId': 'NCT04950959', 'briefTitle': 'XACT ACE Observational Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xact Robotics Ltd.'}, 'officialTitle': 'Observational Post-Market Study of the XACT ACE Robotic System', 'orgStudyIdInfo': {'id': 'CLIN-REG-01-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All subjects', 'description': 'Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting', 'interventionNames': ['Device: Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T']}], 'interventions': [{'name': 'Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T', 'type': 'DEVICE', 'description': "The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.", 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nanette Matrullo', 'role': 'CONTACT', 'email': 'nanette.matrullo@lahey.org', 'phone': '781-744-2906'}, {'name': 'Sebastian Flacke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lahey Hospital and Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}], 'centralContacts': [{'name': 'Mark Macedo', 'role': 'CONTACT', 'email': 'mark.macedo@xactrobotics.com', 'phone': '5082076505'}], 'overallOfficials': [{'name': 'Mark Macedo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'XACT Robotics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xact Robotics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}