Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT01867658
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2013-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dawn.Heimer@crbard.com', 'phone': '401-825-8681', 'title': 'Dawn Heimer', 'organization': 'C.R. Bard Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected through the one month follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant', 'otherNumAtRisk': 112, 'otherNumAffected': 31, 'seriousNumAtRisk': 112, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 12}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arrythmia Supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary Air Leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Multi-organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Post-procedural Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyponaturemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Carcinoid Tumor Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchial Secretion Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchial Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchopleural Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneurmonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary Air Leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Device and/or Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '50.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One (1) month follow-up', 'description': 'The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '57.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One (1) month', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Air Leaks That Are Sealed or Reduced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'Number of Air Leaks', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '98.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'unitOfMeasure': 'percentage of air leaks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Air Leaks', 'denomUnitsSelected': 'Number of Air Leaks', 'populationDescription': 'Subjects in the mITT population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '6.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0-46', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population minus 1 subject with missing data.'}, {'type': 'SECONDARY', 'title': 'Duration of Chest Tube Drainage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '6.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0-46', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population minus 1 subject with missing data'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization (Length of Stay)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '3.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0-20', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population minus 2 subjects who died prior to discharge'}, {'type': 'SECONDARY', 'title': 'Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'classes': [{'title': 'Mental Component Score', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '9.20', 'groupId': 'OG000'}]}]}, {'title': 'Physical Component Score', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '9.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and One (1) Month Follow-up', 'description': 'The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Subject could not be contacted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment began in June 2013. 112 subjects were treated across 15 sites.', 'preAssignmentDetails': '207 subjects were consented and 112 were treated with Progel® PALS. Of the subjects who were not treated, 69 failed to meet intra-operative inclusion criteria (54/94 screened video-assisted subjects and 15/87 screened robotic assisted subjects) and 11 did not have a video or robotics procedure performed (ie, converted to open thoracotomy)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Progel® Pleural Air Leak Sealant', 'description': 'Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '11.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2013-05-03', 'resultsFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2013-05-29', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-23', 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Device and/or Procedure-related Adverse Events', 'timeFrame': 'One (1) month follow-up', 'description': 'The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up', 'timeFrame': 'One (1) month'}, {'measure': 'Percentage of Air Leaks That Are Sealed or Reduced', 'timeFrame': 'Day 0'}, {'measure': 'Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery', 'timeFrame': 'Day 0'}, {'measure': 'Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals', 'timeFrame': 'Day 0-46'}, {'measure': 'Duration of Chest Tube Drainage', 'timeFrame': 'Day 0-46'}, {'measure': 'Duration of Hospitalization (Length of Stay)', 'timeFrame': 'Days 0-20'}, {'measure': 'Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up', 'timeFrame': 'Baseline and One (1) Month Follow-up', 'description': 'The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pleural Air Leak', 'Pulmonary resection', 'Video Assisted', 'Robotic Assisted'], 'conditions': ['Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '27955681', 'type': 'DERIVED', 'citation': 'Park BJ, Snider JM, Bates NR, Cassivi SD, Jett GK, Sonett JR, Toloza EM. Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. J Cardiothorac Surg. 2016 Dec 12;11(1):168. doi: 10.1186/s13019-016-0563-3.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries.\n\nThe data collected in this clinical study will supplement the Approved PMA P010047 Progel® PALS product.', 'detailedDescription': 'This is a prospective, open label, multi-center clinical study designed to assess the safety of the Progel® PALS product, including the Extended Applicator Spray Tip, when used in Video Assisted and Robotic Assisted Thoracoscopic Surgery. The study will treat approximately 105 evaluable subjects at up to 15 U.S. sites. All subjects will provide informed consent prior to enrollment in the study.\n\nPatients who have met the initial screening criteria and who have a visible pleural air leak which requires treatment with a sealant, after standard closure techniques are used (standard sutures, staples or devices supplied by the hospital for thoracoscopic surgery) will be eligible for study participation. If the subject is treated, the surgeon will utilize Progel® PALS to the same sites originally treated with standard technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is willing and able to provide written informed consent.\n* Subject is scheduled for video assisted or robotic assisted thoracoscopic surgery for lung resection (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung volume reduction), decortications or biopsy within 45 days of the screening evaluation.\n* Subject is ≥18 years of age.\n* Subject has a life expectancy ≥6 months.\n* Following lung resection, subject has at least one or more visible intraoperative air leaks, after standard closure techniques are applied, that requires treatment with pleural sealant.\n* Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including the follow-up visits.\n\nExclusion Criteria:\n\n* Subject has undergone previous lung resection or previous use of a sealant for air leaks.\n* Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.\n* Following lung resection, subject has intraoperative air leaks that require non-standard, visceral pleural closure (e.g. leak is too small or tissue is too fragile to use sutures/staples).\n* Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.\n* Subject has known allergy to human albumin or any component in the Progel® PALS product.\n* Subject has an active or latent infection which is systemic or at the intended surgery site.\n* Subject has necrotic or friable borders of the defect that will not support secure suture fixation if use of sutures is required.\n* Subject is participating in another investigational drug or device trial.\n* Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.\n* Subject is part of the site personnel directly involved with this study.\n* Subject is a family member of the investigational study staff.'}, 'identificationModule': {'nctId': 'NCT01867658', 'briefTitle': 'Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery', 'orgStudyIdInfo': {'id': 'NEO12-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progel® Pleural Air Leak Sealant', 'interventionNames': ['Device: Progel® Pleural Air Leak Sealant']}], 'interventions': [{'name': 'Progel® Pleural Air Leak Sealant', 'type': 'DEVICE', 'description': 'Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant', 'armGroupLabels': ['Progel® Pleural Air Leak Sealant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiothoracic & Vascular Surgical Associates, PA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Medical Center, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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