Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-17 @ 12:04 PM
Study NCT ID:
NCT01732120
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Off Clamp Randomization
Sponsor:
Organization:
Raw JSON
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'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'acute pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in eGFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'groupId': 'OG000', 'lowerLimit': '-16.1', 'upperLimit': '-5.3'}, {'value': '-9.4', 'groupId': 'OG001', 'lowerLimit': '-14.0', 'upperLimit': '-4.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 3 months post nephrectomy', 'description': 'Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.', 'unitOfMeasure': 'percent change in eGFR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing 3 postoperative eGFR from the Traditional Partial Nephrectomy group and 6 from the Off-Clamp Partial Nephrectomy group.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Split Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.2', 'groupId': 'OG000', 'lowerLimit': '-15.9', 'upperLimit': '-6.5'}, {'value': '-11.8', 'groupId': 'OG001', 'lowerLimit': '-15.9', 'upperLimit': '-7.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months post nephrectomy', 'description': 'Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.', 'unitOfMeasure': 'percent change in split renal function', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing 1 postoperative renal scan from the Traditional Partial Nephrectomy group and 7 from the Off-Clamp Partial Nephrectomy group.'}, {'type': 'SECONDARY', 'title': 'Percent of Observations With Positive Surgical Margins.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '20.8'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the time of nephrectomy', 'description': 'Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.', 'unitOfMeasure': 'percent of cases with positive margins', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only malignant cases were included in the analysis of positive margins.'}, {'type': 'SECONDARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '184.1', 'spread': '193.3', 'groupId': 'OG000'}, {'value': '178.5', 'spread': '207.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of nephrectomy', 'description': 'Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.', 'unitOfMeasure': 'Milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Observations With Metastasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.', 'unitOfMeasure': 'percent of cases with metastasis on f/u', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only malignant cases were included in the analysis of metastasis on follow-up imaging.'}, {'type': 'SECONDARY', 'title': 'Operative Time Measured in Minutes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '178.0', 'spread': '44.4', 'groupId': 'OG000'}, {'value': '156.0', 'spread': '40.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of nephrectomy', 'description': 'Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Warm Ischemia Time Measured in Minutes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of nephrectomy.', 'description': 'Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Observations With Intra-operative Complications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '13.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of nephrectomy', 'description': 'Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.', 'unitOfMeasure': '% of cases with intraop complications', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hospital Days Post Nephrectomy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of nephrectomy to day of hospital discharge.', 'description': 'Perioperative outcomes will be assessed based number of hospital days post nephrectomy.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Observations With Postoperative Complications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'OG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '32.4'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '29.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 3 months post nephrectomy.', 'description': 'Perioperative outcomes will be assessed based on percent of observations with postoperative complications.', 'unitOfMeasure': '% of cases with postop complications', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'FG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Off-clamp Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.\n\nOff-clamp partial nephrectomy'}, {'id': 'BG001', 'title': 'Traditional Partial Nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-01', 'size': 645497, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-09T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2012-11-16', 'resultsFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-09', 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in eGFR', 'timeFrame': 'baseline and 3 months post nephrectomy', 'description': 'Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.'}, {'measure': 'Percent Change From Baseline in Split Renal Function', 'timeFrame': 'baseline to 3 months post nephrectomy', 'description': 'Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.'}], 'secondaryOutcomes': [{'measure': 'Percent of Observations With Positive Surgical Margins.', 'timeFrame': 'at the time of nephrectomy', 'description': 'Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.'}, {'measure': 'Estimated Blood Loss', 'timeFrame': 'At the time of nephrectomy', 'description': 'Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.'}, {'measure': 'Percent of Observations With Metastasis', 'timeFrame': '3 years', 'description': 'Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.'}, {'measure': 'Operative Time Measured in Minutes.', 'timeFrame': 'At the time of nephrectomy', 'description': 'Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.'}, {'measure': 'Warm Ischemia Time Measured in Minutes.', 'timeFrame': 'At the time of nephrectomy.', 'description': 'Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.'}, {'measure': 'Percent of Observations With Intra-operative Complications.', 'timeFrame': 'At the time of nephrectomy', 'description': 'Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.'}, {'measure': 'Number of Hospital Days Post Nephrectomy.', 'timeFrame': 'Day of nephrectomy to day of hospital discharge.', 'description': 'Perioperative outcomes will be assessed based number of hospital days post nephrectomy.'}, {'measure': 'Percent of Observations With Postoperative Complications.', 'timeFrame': 'Within 3 months post nephrectomy.', 'description': 'Perioperative outcomes will be assessed based on percent of observations with postoperative complications.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['off-clamp', 'partial nephrectomy', 'renal cancer treatment', 'renal ischemia'], 'conditions': ['Renal Cancer', 'Renal Ischemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 18 and older.\n* Patients willing and able to sign consent.\n* Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).\n* Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.\n\nExclusion Criteria:\n\n* Patients under 18.\n* Patients with Karnofsky Performance Status (KPS) less than 40.\n* Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).\n* Patients with bilateral synchronous renal masses.\n* Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.\n* Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)"}, 'identificationModule': {'nctId': 'NCT01732120', 'briefTitle': 'Off Clamp Randomization', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors', 'orgStudyIdInfo': {'id': 'myIRB ID 201208091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Off-clamp partial nephrectomy', 'description': 'Partial nephrectomy will be performed without clamping of the renal blood vessels.', 'interventionNames': ['Procedure: Off-clamp partial nephrectomy']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional partial nephrectomy', 'description': 'Partial nephrectomy will be performed with clamping of the renal blood vessels.'}], 'interventions': [{'name': 'Off-clamp partial nephrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Off-clamp partial nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Robert S Figenshau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Midwest Stone Institute.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}