Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-28 @ 9:28 AM
Study NCT ID:
NCT02952261
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2016-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Application of 3D Printing Technique in Small Pulmonary Nodule Localization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chenthoracic@163.com', 'phone': '+86 13816869003', 'title': 'Dr. Chang Chen', 'organization': 'Shanghai Pulmonary Hospital affiliated to Tongji university'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.', 'eventGroups': [{'id': 'EG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 28, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.", 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 16, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'pnueumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Lung Nodule Localization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.'}, {'id': 'OG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the time of completing final CT scan, assessed up to 2 days.', 'description': 'Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat analysis (patients who did not receive lung nodule localization were excluded.(n=10))'}, {'type': 'SECONDARY', 'title': 'Procedural Duration of the Nodule Localization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.'}, {'id': 'OG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the time of completing final CT scan, assessed up to 1 hour.', 'description': 'Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.', 'unitOfMeasure': 'min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiation Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.'}, {'id': 'OG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."}], 'classes': [{'categories': [{'measurements': [{'value': '313', 'spread': '84', 'groupId': 'OG000'}, {'value': '229', 'spread': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the time of completing final CT scan, assessed up to 1 hour.', 'description': 'Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.', 'unitOfMeasure': 'mGy*cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.'}, {'id': 'OG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of completing final CT scan, assessed up to 2 days.', 'description': 'Pnuemothorax related to lung nodule localization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.'}, {'id': 'FG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The recruitment process was from October 15, 2016 to October 26, 2017. And, the first participant was recruited on October 24, 2016. Until reaching to 40% of prespecified sample size (Janunary 1, 2017) , interim analysis was conducted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CT-guided Localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.\n\nCT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.'}, {'id': 'BG001', 'title': 'Template-guided Localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.\n\ntemplate-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'spread': '11', 'groupId': 'BG000'}, {'value': '54', 'spread': '15', 'groupId': 'BG001'}, {'value': '53', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Smoking history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'YES', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'NO', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI(body mass index)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22.9', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '22.8', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '22.9', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1（of percentage predicted）', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93.6', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '94.3', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '94.0', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage predicted FEV1', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nodule size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '10.1', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'nodule size measured by long-axis diameter', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nodule location', 'classes': [{'title': 'right upper lobe(RUL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'right middle lobe(RML)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'right lower lobe(RLL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'left upper lobe(LUL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'left lower lobe(LLL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nodule type', 'classes': [{'title': 'pure ground glass opacity(GGO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Mixed ground glass opacity(GGO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Solid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Distance from pleura', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '35.9'}, {'value': '8.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '43.9'}, {'value': '7.8', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '43.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-01', 'size': 782392, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-01T12:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-01', 'studyFirstSubmitDate': '2016-10-31', 'resultsFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-01', 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Lung Nodule Localization', 'timeFrame': 'From the time of completing final CT scan, assessed up to 2 days.', 'description': 'Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)'}], 'secondaryOutcomes': [{'measure': 'Procedural Duration of the Nodule Localization', 'timeFrame': 'From the time of completing final CT scan, assessed up to 1 hour.', 'description': 'Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.'}, {'measure': 'Radiation Dose', 'timeFrame': 'From the time of completing final CT scan, assessed up to 1 hour.', 'description': 'Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.'}, {'measure': 'Complication Rate', 'timeFrame': 'From the time of completing final CT scan, assessed up to 2 days.', 'description': 'Pnuemothorax related to lung nodule localization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Printing, Three-dimensional'], 'conditions': ['Lung Neoplasm', 'Thoracic Surgery, Video-Assisted']}, 'referencesModule': {'references': [{'pmid': '29017792', 'type': 'BACKGROUND', 'citation': 'Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1.'}, {'pmid': '30586136', 'type': 'DERIVED', 'citation': 'Zhang L, Wang L, Kadeer X, Zeyao L, Sun X, Sun W, She Y, Xie D, Li M, Zou L, Rocco G, Yang P, Chen C, Liu CC, Petersen RH, Ng CSH, Parrish S, Zhang YS, Giordano R, di Tommaso L; AME Thoracic Surgery Collaborative Group. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2019 Apr 1;154(4):295-303. doi: 10.1001/jamasurg.2018.4872.'}]}, 'descriptionModule': {'briefSummary': 'The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.', 'detailedDescription': 'Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged from 19 to 80 years\n2. lesions located in peripheral lung tissue which can be removed by wedge resection\n3. The maximum diameter of the lesion is no more than 20 mm.\n4. Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization\n5. Informed consent was signed voluntarily.\n\nExclusion Criteria:\n\n1. nodule located in the scapula region.\n2. there were two or more lung nodules needed to be localized."}, 'identificationModule': {'nctId': 'NCT02952261', 'briefTitle': 'Application of 3D Printing Technique in Small Pulmonary Nodule Localization', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pulmonary Hospital, Shanghai, China'}, 'officialTitle': 'Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'k16-284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CT-guided localization', 'description': 'This group of participants received conventional CT-guided lung nodule localization.', 'interventionNames': ['Other: CT-guided localization']}, {'type': 'EXPERIMENTAL', 'label': 'template-guided localization', 'description': "Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.", 'interventionNames': ['Device: template-guided localization']}], 'interventions': [{'name': 'template-guided localization', 'type': 'DEVICE', 'description': 'Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.', 'armGroupLabels': ['template-guided localization']}, {'name': 'CT-guided localization', 'type': 'OTHER', 'description': 'Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.', 'armGroupLabels': ['CT-guided localization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chang Chen, MD,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of thoracic surgery', 'investigatorFullName': 'Chang Chen', 'investigatorAffiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}}}}