Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-05 @ 12:53 PM
Study NCT ID:
NCT02174302
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities.', 'timeFrame': '1 hour'}, {'measure': 'Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.', 'timeFrame': '1 hour'}, {'measure': 'Image quality of images in different SPIES modalities', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Differences in time to start delineation between images in different SPIES modalities', 'timeFrame': '1 hour'}, {'measure': 'Differences in time needed per image in different SPIES modalities', 'timeFrame': '1 hour'}, {'measure': "Differences in use of úndo' button between different SPIES modalities", 'timeFrame': '1 hour'}, {'measure': 'Differences in participants who are familiar with image enhancement system (NBI/SPIES) vs participants who are not familiar working with them.', 'timeFrame': '1 hour'}, {'measure': 'Differences in interpretation of images between participants with a visual impairment or colourblindness vs participants without.', 'timeFrame': '1 hour'}, {'measure': 'Differences in interpretations between participants in age or experience in TURBT annually.', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet Computer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.croesoffice.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Comparison of Images of the same area in the bladder in four different SPIES modalities on a tablet computer. Participants are asked to delineate the area on the image suspect for malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s) is/are captured. Time to start the drawing and total time per image are captured. Hereafter, an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10 being best possible.', 'detailedDescription': 'Karl Storz Company has recently introduced the Storz Professional Image Enhancement System. To evaluate the interpretation of cystoscopy images in different SPIES modalities a tablet program was developed. Images of 20 bladder areas were captured in 4 different SPIES modalities; white light, Clara\\&Chroma, Spectra A and Spectra B. Of each bladder area, one extra image was added to the program, so that a total of 100 images were interpreted.\n\nEvery image is shown 45 seconds on the tablet screen. Participants are asked to delineate with a stylus on the tablet the precise area they suspect to be malignant and would resect or treat. After they are done they go to the next slide and the time is stopped.After each image, participants are asked to judge the quality of the image on a scale of zero to ten, with zero being the worst and ten the best.After this judgement, the next image for interpretation is presented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'urologists and resident urologist', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* urologist or resident urologist\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02174302', 'briefTitle': 'Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Research Office of the Endourological Society'}, 'officialTitle': 'Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities', 'orgStudyIdInfo': {'id': '2014-6'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Research Office of the Endourological Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}