Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02053168
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dawn.Heimer@crbard.com', 'phone': '401-825-8681', 'title': 'Dawn Heimer', 'organization': 'BD Interventional - Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 months post index procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Superficial surgical site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Wound necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Stomal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Myocardial hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal wall wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Hernia Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '>24 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Post Op to End of Study', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months', 'description': 'A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Months', 'description': 'In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Carolinas Comfort Scale (CCS) Total Score - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months postoperative', 'description': 'The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with non-missing values at both baseline and respective post procedure assessment.'}, {'type': 'SECONDARY', 'title': 'Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '9.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months postoperative', 'description': 'Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with non-missing values at both baseline and respective post procedure assessment.'}, {'type': 'SECONDARY', 'title': 'Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.4', 'spread': '9.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months postoperative', 'description': 'Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with non-missing values at both baseline and respective post procedure assessment.'}, {'type': 'SECONDARY', 'title': 'Surgical Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '242.5', 'spread': '132.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of index procedure (mean of 242.5 mins)', 'description': 'Measured from incision to closure (skin to skin).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '4.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Months', 'description': 'Measured from end of index procedure to hospital discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Study Related Post Operative Surgical Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Study Related Post Operative New Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Related Post-operative Visits Unrelated to Standard of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Seroma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of 33 subjects enrolled, 8 were not treated with the study device: a contraindication to the placement of mesh was present in 4 subjects; complete removal of existing mesh from a prior hernia repair (in the same affected area) was not possible in 3 subjects; and 1 subject had an active or latent systemic infection.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Resorbable Mesh', 'description': 'Phasix Mesh\n\nResorbable Mesh: Phasix Mesh'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '17.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', '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': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'spread': '17.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.9', 'spread': '7.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '5.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-21', 'size': 925242, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-26T09:47', 'hasProtocol': True}, {'date': '2017-02-02', 'size': 364577, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-26T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2014-01-31', 'resultsFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-10', 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Hernia Recurrence', 'timeFrame': '1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months', 'description': 'A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Device Related Adverse Events', 'timeFrame': '24 Months', 'description': 'In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.'}, {'measure': 'Carolinas Comfort Scale (CCS) Total Score - Change From Baseline', 'timeFrame': 'Baseline and 24 months postoperative', 'description': 'The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.'}, {'measure': 'Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)', 'timeFrame': 'Baseline and 24 months postoperative', 'description': 'Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.'}, {'measure': 'Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)', 'timeFrame': 'Baseline and 24 months postoperative', 'description': 'Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.'}, {'measure': 'Surgical Procedure Time', 'timeFrame': 'Duration of index procedure (mean of 242.5 mins)', 'description': 'Measured from incision to closure (skin to skin).'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '10 Months', 'description': 'Measured from end of index procedure to hospital discharge'}, {'measure': 'Number of Study Related Post Operative Surgical Procedures', 'timeFrame': '24 Months'}, {'measure': 'Number of Study Related Post Operative New Hospital Admissions', 'timeFrame': '24 Months'}, {'measure': 'Number of Related Post-operative Visits Unrelated to Standard of Care', 'timeFrame': '24 Months'}, {'measure': 'Incidence of Seroma', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventral Hernia', 'Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.', 'detailedDescription': 'Pilot Study of patients across all wound classes for recurrence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject or subject's legally authorized representative must be willing to give written informed consent\n* Subject must be diagnosed with ventral or incisional hernia\n* Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.\n\nExclusion Criteria:\n\n* Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).\n* Subject's hernia has recurred four or more times.\n* Subject's body mass index (BMI) \\>40 kg/m2.\n* Subject has peritonitis.\n* Subject is on or suspected to be placed on chemotherapy medications during any part of the study.\n* Chronic steroid use or immunosuppression drugs (\\> 6 months).\n* Subject has cirrhosis, and/or ascites.\n* Subject is American Society of Anesthesiology Class 4 or 5.\n* Subject is pregnant or planning to become pregnant during the course of the study.\n* Subject is known to be infected with human immunodeficiency virus (HIV).\n* Subject has a life expectancy of less than 2 years at the time of enrollment.\n* Subject has been treated with an investigational product in the past 30 days.\n* Subject is part of the site personnel directly involved with this study\n* Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.\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"}, 'identificationModule': {'nctId': 'NCT02053168', 'briefTitle': 'A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair', 'orgStudyIdInfo': {'id': 'DVL-HE-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Resorbable Mesh', 'description': 'Phasix Mesh', 'interventionNames': ['Device: Resorbable Mesh']}], 'interventions': [{'name': 'Resorbable Mesh', 'type': 'DEVICE', 'description': 'Phasix Mesh', 'armGroupLabels': ['Resorbable Mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Hernia Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Celebration Health', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Physicians Clinic', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Yuri Novitsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}