Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT04486560
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lyarmus@jhmi.edu', 'phone': '410-502-5224', 'title': 'Dr. Lonny Yarmus', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'All procedures were performed at large academic centers so procedural volume and pathology may not be generalizable. Larger proportion of lung transplant patients enrolled means there is a lack of heterogeneity in disease entities. Study aimed to address safety so the design and sample size is too small to accurately estimate diagnostic yield. Sheath was required for all cases, precluding use of robotic-assisted bronchoscopy (and underrepresentation of lung cancer).'}}, 'adverseEventsModule': {'timeFrame': 'Day of procedure through 30 days post-procedure', 'description': 'Primary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade ≥ 3, pneumothorax grade ≥ 2, post-procedure respiratory failure, and/or death related to the device.\n\nSecondary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade \\< 3 and/or pneumothorax grade \\< 2 related to the device.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 22, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'SECONDARY SAFETY ENDPOINT Adverse Event', 'notes': 'Occurrence of bleeding grade \\< 3 and/or pneumothorax grade \\< 2 related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of procedure', 'description': 'The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Minor Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'title': 'Grade 1 Pneumothorax', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1-2 Bleeding', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of procedure', 'description': 'The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Histologic Accessibility Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Grade 0: Does not contain alveolar structures and can therefore not be assessed\n\nGrade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features\n\nGrade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible\n\nGrade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible\n\nGrade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible\n\nGrade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible\n\nGrade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'title': 'Lung Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Diffuse Lung Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary Parenchymal Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure, up to 1 hour', 'description': 'Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was broken down by type of cryobiopsy indication.'}, {'type': 'SECONDARY', 'title': 'Total Histologic Area (Square Millimeters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '87.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Amount of total histologic tissue in square millimeters observed under microscope.', 'unitOfMeasure': 'square millimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alveolated Area (Square Millimeters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Number of Pieces', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'title': 'Per Patient', 'categories': [{'measurements': [{'value': '11.39', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '51.6'}]}]}, {'title': 'Per Piece', 'categories': [{'measurements': [{'value': '2.47', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Total amount of area in square millimeters containing alveoli.', 'unitOfMeasure': 'square millimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Pieces', 'denomUnitsSelected': 'Number of Pieces'}, {'type': 'SECONDARY', 'title': 'Open Alveoli Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Number of Samples', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '66.48', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Percentage of all alveoli that are open.', 'unitOfMeasure': 'percent', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Samples', 'denomUnitsSelected': 'Number of Samples'}, {'type': 'SECONDARY', 'title': 'Percent Crush Artifact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Number of samples', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.', 'unitOfMeasure': 'percent', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of samples', 'denomUnitsSelected': 'Number of samples'}, {'type': 'SECONDARY', 'title': 'Artifact Free Lung Parenchyma Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Number of Samples', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '90.86', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.', 'unitOfMeasure': 'percent', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Samples', 'denomUnitsSelected': 'Number of Samples'}, {'type': 'SECONDARY', 'title': 'Activation Time (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of procedure, up to 1 hour', 'description': 'Time of activation of cryoprobe.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of procedure, up to 1 hour', 'description': 'Time for entire procedure measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.\n\nERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Status', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Current', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Former', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for Biopsy', 'classes': [{'categories': [{'title': 'Pulmonary Parenchymal Lesion', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Diffuse Lung Disease', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Lung Transplant', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Airway', 'classes': [{'categories': [{'title': 'Laryngeal Mask Airway', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Endotracheal Tube', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Rigid Bronchoscopy', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bronchial Blocker Used', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in whom bronchial blocker was used.', 'unitOfMeasure': 'Participants'}, {'title': 'Location of Biopsy', 'classes': [{'categories': [{'title': 'Right Upper Lobe', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Right Middle Lobe', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Right Lower Lobe', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Left Upper Lobe', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Left Lower Lobe', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-01', 'size': 504653, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-13T17:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a multi-center, non-randomized, single-arm, prospective trial. Therefore, all participants will have their transbronchial biopsy with the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2020-07-21', 'resultsFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-10', 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': 'Within 30 days of procedure', 'description': 'The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Minor Adverse Events', 'timeFrame': 'Within 30 days of procedure', 'description': 'The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).'}, {'measure': 'Mean Histologic Accessibility Grade', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Grade 0: Does not contain alveolar structures and can therefore not be assessed\n\nGrade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features\n\nGrade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible\n\nGrade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible\n\nGrade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible\n\nGrade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible\n\nGrade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features'}, {'measure': 'Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis', 'timeFrame': 'During procedure, up to 1 hour', 'description': 'Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.'}, {'measure': 'Total Histologic Area (Square Millimeters)', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Amount of total histologic tissue in square millimeters observed under microscope.'}, {'measure': 'Alveolated Area (Square Millimeters)', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Total amount of area in square millimeters containing alveoli.'}, {'measure': 'Open Alveoli Percent', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Percentage of all alveoli that are open.'}, {'measure': 'Percent Crush Artifact', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.'}, {'measure': 'Artifact Free Lung Parenchyma Percent', 'timeFrame': 'Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)', 'description': 'Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.'}, {'measure': 'Activation Time (Seconds)', 'timeFrame': 'At the time of procedure, up to 1 hour', 'description': 'Time of activation of cryoprobe.'}, {'measure': 'Procedure Time', 'timeFrame': 'At the time of procedure, up to 1 hour', 'description': 'Time for entire procedure measured in minutes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['lung', 'cryoprobe', 'bronchoscopic', 'biopsy'], 'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and collect data on the initial effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for transbronchial lung biopsy via a bronchoscopic approach.', 'detailedDescription': 'A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe.\n\nThis study does not involve randomization or assigning different patients to different procedures to compare. Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. The only difference from the standard of care approach is that the physician performing the transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.\n\nPatients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female, ≥ 18-years-old\n* Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist\n\nExclusion Criteria:\n\n* Pregnant or nursing females, or females of child bearing potential who refuse to take a pregnancy test prior to enrollment\n* Individuals with current or recent systematic conditions, such as uncontrolled hypertension (systolic \\> 200 mmHg or diastolic \\> 110 mmHg), type 1 diabetes, severe pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or myocardial infarction (within the last 3 months)\n* Presence of bleeding disorder\n* Platelet count \\<50,000\n* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)\n* International Normalized Ratio (INR) \\<1.5\n* Robotic Bronchoscopy'}, 'identificationModule': {'nctId': 'NCT04486560', 'acronym': 'FROSTBITE', 'briefTitle': 'Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (The FROSTBITE Trial)', 'orgStudyIdInfo': {'id': 'IRB00235679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm: Cryoprobe', 'description': 'Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.', 'interventionNames': ['Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651']}], 'interventions': [{'name': 'ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651', 'type': 'DEVICE', 'description': 'ERBE 1.1mm flexible single-use cryoprobe with oversheath', 'armGroupLabels': ['Single Arm: Cryoprobe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Lonny Yarmus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erbe USA Incorporated', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}