Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-29 @ 12:51 PM
Study NCT ID:
NCT06053892
Status:
TERMINATED
Last Update Posted:
2025-09-08
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The assignment into the study groups is going to be performed by 1:1 randomization using randomisation cards which are drawn by author-ised study staff.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Difficulties in recruiting and implementing the study design due to missing ressources.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Augmented reality sonography is less time consuming', 'timeFrame': '10 minutes', 'description': 'Puncturing shoulders with Augmented reality sonography is faster (measuring the time in minutes and seconds) than when using standard sonography- from point of entry the skin until the target'}], 'secondaryOutcomes': [{'measure': 'Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing', 'timeFrame': '10 minutes (ml aspirated) to 3 days (laboratory results)', 'description': 'More fluid (measured in ml) can be aspirated with lower false negative results (laboratory results) when puncutring shoulders with US-guidance in comparison to fluoroscopic guidance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Interventions']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to prospectively evaluate the potential benefits of injections with Augmented Reality enhanced Ulrasound versus standard Ultrasound or fluoroscopy participants where assigend for fluoroscopic joint injections oder for Ultrasound guided injection.\n\nThe main question\\[s\\] it aims to answer are:\n\n* The primary objective is to evaluate the duration of the different interventions\n* the count of needle passes\n* assess the reduction of radiation exposure using AR US rather than fluoroscopic guidance for joint injections', 'detailedDescription': 'Patients assigned for standard Ultrasound or fluoroscopic joint injection are informed about the trial. Participants are randomly assigned to the study or control intervention. 1:1 randomization is used.\n\nIn both groups, data on duration of the intervention, count of needle passes, correctness of injection location and radiation exposure will be collected. The outcome measures will be compared between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients 18 to 99 years of age\n* Patients assigned for fluoroscopic guided injections (including MR arthrographies)\n* Patients assigned for US guided injections (including MR arthrographies)\n\nExclusion Criteria:\n\n* \\- Patients who are not willing to be part of the study\n* Contraindication against fluoroscopic guided injection\n* Women who are pregnant or breast feeding (Pregnancy assessment is part of the routine prior to fluoroscopic joint injections. No pregnancy test will be done for this study.)'}, 'identificationModule': {'nctId': 'NCT06053892', 'briefTitle': 'AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections', 'orgStudyIdInfo': {'id': 'R471'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AR US', 'description': 'Augmented reality sonography guidance for shoulder punctures', 'interventionNames': ['Diagnostic Test: Puncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard US', 'description': 'standard sonography guidance for shoulder punctures', 'interventionNames': ['Diagnostic Test: Puncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoroscopic', 'description': 'Fluroscopic guidance for shoulder punctures', 'interventionNames': ['Diagnostic Test: Puncture']}], 'interventions': [{'name': 'Puncture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Shoulder puncture with the newly designed technique using AR to overlie the US image to the imaged anatomical structures in comparision to standard US and flurosopic-guidance.', 'armGroupLabels': ['AR US', 'Fluoroscopic', 'standard US']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}