Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
Study NCT ID:
NCT03943368
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2019-05-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Virtual Reality (VR) Models for Robotic Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative PSA', 'timeFrame': 'Up to 24 months', 'description': 'PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months'}], 'secondaryOutcomes': [{'measure': 'Surgical Margin Status', 'timeFrame': 'Immediately postoperatively', 'description': 'Defined as positive or negative surgical margin'}, {'measure': 'Androgen Deprivation or Radiation Therapy', 'timeFrame': 'Up to 24 months postoperatively', 'description': 'Any occurrence of salvage or adjuvant therapy post surgery'}, {'measure': 'Postoperative Erectile Function', 'timeFrame': 'Up to 24 months postoperatively', 'description': 'Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months'}, {'measure': 'Postoperative Urinary Function', 'timeFrame': 'Up to 24 months postoperatively', 'description': 'Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '39283633', 'type': 'DERIVED', 'citation': 'Shirk JD, Reiter RE, Wallen EM, Pak RW, Ahlering T, Badani KK, Porter JR. Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434143. doi: 10.1001/jamanetworkopen.2024.34143.'}, {'pmid': '35848770', 'type': 'DERIVED', 'citation': 'Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18.'}]}, 'descriptionModule': {'briefSummary': "A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is undergoing robotic prostatectomy being performed by participating surgeon\n* Patient is willing to be randomized between intervention and control arms\n\nExclusion Criteria:\n\n* Patients with prior pelvic radiation\n* Patients with prior androgen deprivation therapy\n* Patients with prior localized ablative therapy\n* Patients with prior TURP or other surgical BPH treatment'}, 'identificationModule': {'nctId': 'NCT03943368', 'briefTitle': 'Using Virtual Reality (VR) Models for Robotic Prostatectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ceevra, Inc.'}, 'officialTitle': 'Using Virtual Reality (VR) Models for Robotic Prostatectomy', 'orgStudyIdInfo': {'id': '20171006RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention Arm', 'description': 'Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case.', 'interventionNames': ['Device: Ceevra Reveal']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Subjects whose surgeon will only be viewing MR images in connection with the case.'}], 'interventions': [{'name': 'Ceevra Reveal', 'type': 'DEVICE', 'description': '3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.', 'armGroupLabels': ['Experimental: Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90094', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Urology Group', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Medical Center'}, {'name': 'Raymond Pak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Thomas Ahlering, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Irvine'}, {'name': 'Robert Reiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA Urology'}, {'name': 'Ketan Badani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ceevra, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}