Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT00792961
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2008-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-07', 'studyFirstSubmitDate': '2008-11-16', 'studyFirstSubmitQcDate': '2008-11-16', 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endomicroscopy images captured from prostate and surrounding tissues', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'Comparison with conventional histology from corresponding biopsies or resection specimens', 'timeFrame': "Post-surgery, after pathologist's review"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Robotic surgery', 'Endomicroscopy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery. This feasibility study is largely descriptive, and will use endomicroscopy to document the cellular and architectural appearance of tissue during minimally invasive prostate surgery for later comparison with features seen upon conventional histopathological examination of biopsies or resection specimens.', 'detailedDescription': 'Prostate surgery requires meticulous dissection around nerves and associated structures such as the bladder, seminal vesicles and vas deferens. Nerve damage during prostatectomy can result in undesirable outcomes such as impotence and urinary incontinence. Robot assisted minimally invasive prostatectomy offers enhanced visualisation of the surgical field. Superior clinical outcomes in terms of length of hospital stay, blood loss, and oncologic margins compared with open surgery are reported. Confocal endomicroscopy provides high resolution subsurface cellular imaging in real time and is already in clinical use in gastroenterology and under investigation in other surgical applications. A potential role exists for confocal endomicroscopy to enhance microscopic nerve identification intra-operatively and guide surgical decision making during robot-assisted prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients with allergy or prior adverse reaction to Fluorescein Sodium\n* Patients unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00792961', 'briefTitle': 'Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optiscan Pty Ltd'}, 'officialTitle': 'In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study', 'orgStudyIdInfo': {'id': '13082008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endomicroscopy', 'description': "Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery", 'interventionNames': ['Device: Endomicroscopy']}], 'interventions': [{'name': 'Endomicroscopy', 'type': 'DEVICE', 'description': 'Rigid drop-in endomicroscope imaging probe', 'armGroupLabels': ['Endomicroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The Hospital at Westlake Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Randy Fagin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital at Westlake Medical Center'}, {'name': 'Peter Delaney, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Optiscan Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Delaney', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital at Westlake', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Technology', 'investigatorFullName': 'Peter Delaney', 'investigatorAffiliation': 'Optiscan Pty Ltd'}}}}