Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT06550193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AR/VR for Ultrasound-guided Medical Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure success rate (Primary Block)', 'timeFrame': 'Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU', 'description': 'Document the block result in pre-op, if feasible, or PACU by testing sensory (cold spray) and motor function on all nerves covered by the block'}, {'measure': 'Post-operative opioid consumption', 'timeFrame': '12 hours after surgery', 'description': 'Morphine milligram equivalents (MME) will be measured post-operatively'}, {'measure': 'Post-operative pain scores', 'timeFrame': '12 hours after surgery', 'description': 'Trend pain scores on 11-point NRS scale (from 0 to 10) following the procedure'}], 'secondaryOutcomes': [{'measure': 'Clinician satisfaction', 'timeFrame': 'Within 24 hours of block completion', 'description': "A short survey will be utilized to gather data on clinicians' perceptions of the ease of use, effectiveness, and overall experience with AR/VR tools compared to traditional methods."}, {'measure': 'Procedure duration', 'timeFrame': 'During the procedure', 'description': 'Time of procedure from initial needle insertion to needle removal will be calculated'}, {'measure': 'Needle pass/redirection', 'timeFrame': 'During the procedure', 'description': 'The number of times a clinician must remove the needle from the patient completely and reattempt will be calculated.'}, {'measure': 'Needle visualisation', 'timeFrame': 'Within 24 hours of block completion', 'description': 'A subjective score will be assessed on a short survey to clinicians.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound-guided procedure', 'nerve block'], 'conditions': ['Augmented Reality', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'The study seeks to assess the efficacy of incorporating augmented reality (AR) or virtual reality (VR) technology into ultrasound-guided medical procedures such as regional anesthesia and line placement. By utilizing AR/VR devices, the investigators will improve the ergonomics when using ultrasound to guide procedures. The aims are to enhance visualization of anatomical structures and improve procedural accuracy for clinicians. The study aims to evaluate the feasibility, and effectiveness of integrating AR/VR technology into ultrasound-guided procedures, with the ultimate goal of improving patient outcomes.', 'detailedDescription': 'The investigators aim to learn several key insights from this study. Firstly, they hope to determine the extent to which augmented reality (AR) or virtual reality (VR) technology can enhance the precision and accuracy of ultrasound-guided medical procedures, such as regional anesthesia and line placement. This includes evaluating whether AR/VR visualization leads to improved needle placement and reduced complication rates.\n\nFurthermore, the investigators aim to evaluate the usability and acceptance of AR/VR technology among clinicians, considering factors such as user experience, comfort, and integration with existing workflow processes.\n\nThe importance of this new knowledge lies in its potential to improve medical practice by leveraging cutting-edge technology to improve patient outcomes and expand access to quality healthcare globally. If AR/VR proves to be effective in enhancing procedural accuracy, it could lead to significant advancements in healthcare delivery, particularly in underserved communities and resource-limited settings by leveraging remote care. Additionally, insights gained from this study could inform the development of future AI assisted AR/VR applications in medicine, driving innovation and improving the standard of care across various medical specialties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients presenting for ultrasound-guided procedures, with ASA physical status I, II, or III.\n\nExclusion Criteria:\n\n* pregnancy\n* incarceration\n* BMI \\>35'}, 'identificationModule': {'nctId': 'NCT06550193', 'briefTitle': 'AR/VR for Ultrasound-guided Medical Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of Ultrasound-guided Medical Procedures', 'orgStudyIdInfo': {'id': '75204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR/VR', 'description': 'AR/VR technology for ultrasound-guided procedures.', 'interventionNames': ['Device: Ultrasound-guided procedure using AR/VR technology']}], 'interventions': [{'name': 'Ultrasound-guided procedure using AR/VR technology', 'type': 'DEVICE', 'description': 'Participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures (e.g., regional anesthesia, line placement). All participants will receive standard pre- and post-block or line care as they normally would for the ultrasound-guided procedure.', 'armGroupLabels': ['AR/VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Ksenia Kasimova, MD', 'role': 'CONTACT', 'email': 'kasimova@stanford.edu', 'phone': '650-788-9458'}, {'name': 'Jean Louis-Horn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Jean-Louis Horn, MD', 'role': 'CONTACT', 'email': 'hornj@stanford.edu', 'phone': '5033811645'}, {'name': 'Ksenia (kasimova), MD', 'role': 'CONTACT', 'email': 'kasimova@stanford.edu', 'phone': '6507889458'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology, Perioperative and Pain Medicine', 'investigatorFullName': 'Jean-Louis Horn', 'investigatorAffiliation': 'Stanford University'}}}}