Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT05748106
Status:
UNKNOWN
Last Update Posted:
2023-03-01
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations', 'timeFrame': 'Up to 26 weeks', 'description': 'How does imaging with the K3900 compare with imaging currently used to guide solid organ biopsies or ablations, usually standard ultrasound, fluoroscopy, and/or CT?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound Imaging', 'Interventional Radiology', 'Image-guided biopsy', 'Image-guided tumor ablation', 'Image-guided procedures'], 'conditions': ['Image-Guided Biopsies and/or Ablations']}, 'descriptionModule': {'briefSummary': 'This is an observational study comparing a novel ultrasound-based imaging system (MAUI K3900) to standard-of-care (SoC) imaging systems used to guide and/or manage interventional radiologic procedures such as solid organ biopsies or lesion ablations.', 'detailedDescription': "The purpose of this study is to obtain images using the MAUI Imaging Inc.'s K3900 Ultrasound System and compare them to images captured with FDA cleared imaging devices including traditional ultrasound, CT, MRI and Xray, and to study device safety. The information obtained in this study will inform MAUI Imaging as to what specific follow-on studies will be done in support of appropriate FDA clearances and/or claims. No diagnostic or patient management decisions will be made using the MAUI K3900 Ultrasound System in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient undergoing a standard / routine interventional radiologic procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing standard / routine interventional radiologic procedure\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05748106', 'briefTitle': 'Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities', 'organization': {'class': 'INDUSTRY', 'fullName': 'MAUI Imaging, Inc.'}, 'officialTitle': 'Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures', 'orgStudyIdInfo': {'id': '20203900a'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound-based imaging', 'type': 'DEVICE', 'otherNames': ['K3900'], 'description': 'Ultrasound-based imaging'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Noah B Appel, MD', 'role': 'CONTACT', 'email': 'NoahAppel@texashealth.org', 'phone': '214-345-7700'}, {'name': 'Noah B Appel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Health Presbyterian Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'John C Cheronis, MD/PhD', 'role': 'CONTACT', 'email': 'john.cheronis@mauiimaging.com', 'phone': '3034354074'}], 'overallOfficials': [{'name': 'John C Cheronis, MD/PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MAUI Imaging, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MAUI Imaging, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Texas Health Resources', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}