Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 11:07 AM
Study NCT ID:
NCT07259759
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JURA Study - Observational First-in-human Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality of the JURA System v. 1.0 in humans', 'timeFrame': 'Intra-Operative', 'description': 'Image quality of the JURA System v. 1.0 in humans using an image quality assessment score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Imaging']}, 'descriptionModule': {'briefSummary': 'Evaluate the functionality of the JURA System v. 1.0', 'detailedDescription': 'Evaluate the functionality of the JURA System v. 1.0 in humans under real clinical conditions in the operating room'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women above the age of 18 year, scheduled for an elective abdominal minimal invasive surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Men and women ≥ 18 years of age\n2. Patient scheduled for an elective abdominal minimal invasive surgery\n\nKey Exclusion Criteria:\n\n1. Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women\n2. Individuals who are unable to fully understand all aspects of the study as relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced due to of a compromised position, expectation or benefits or fear or retaliation'}, 'identificationModule': {'nctId': 'NCT07259759', 'acronym': 'JURA', 'briefTitle': 'JURA Study - Observational First-in-human Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuitive Surgical'}, 'officialTitle': 'JURA Study - Observational First-in-human Feasibility Study', 'orgStudyIdInfo': {'id': '1145917C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'JURA Group', 'description': 'Visualization of organs, structures and tissue of interest using the JURA System during a surgical procedure. The surgical procedure itself will be conducted exclusively following the site standard of care.', 'interventionNames': ['Device: Visualization / Imaging']}], 'interventions': [{'name': 'Visualization / Imaging', 'type': 'DEVICE', 'description': 'Visualization / Imaging of organs, structures and tissue of interest using the JURA system such as for example spleen, anastomosis of colon, omental fat, pancreas', 'armGroupLabels': ['JURA Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333', 'city': 'Leiden', 'state': 'ZA', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Alex L. Vahrmeijer, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'centralContacts': [{'name': 'Sylvain Gioux', 'role': 'CONTACT', 'email': 'sylvain.gioux@intusurg.com', 'phone': '+41799246664'}, {'name': 'Petra Kremer', 'role': 'CONTACT', 'email': 'petra.kremer@intusurg.com', 'phone': '+49 151 62679136'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}