Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 6:10 PM
Study NCT ID:
NCT01364233
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2011-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edrower@medline.com', 'phone': '847-643-3874', 'title': 'Ed Drower', 'organization': 'Medline Industries, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'MotifMesh', 'description': 'Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh\n\nMotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh\n\nMotifMESH: Surgical mesh', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hematoma', 'notes': 'Small hematoma located in the lateral incision for performance of a components release, hematoma was drained and resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hematoma'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hernia Occurrence at One Year After Surgery', 'description': 'Number of subjects who had an additional hernia occur following surgery with Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh post 1 year after initial surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Hernia occurrence at one year after surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MotifMesh', 'description': 'Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh\n\nMotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh\n\nMotifMESH: Surgical mesh'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MotifMesh', 'description': 'Participants received Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2011-05-27', 'resultsFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-05', 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh', 'timeFrame': '1 year', 'description': 'Hernia occurrence at one year after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hernia']}, 'descriptionModule': {'briefSummary': 'This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).', 'detailedDescription': 'cPTFEi s a mesh-like product designed to reduce associated post surgical complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHas a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired\n\nExclusion Criteria:\n\nNon-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study\n\nConfirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction\n\nAcceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.\n\nFor subjects with Diabetes Mellitus, HbA1C \\<12%\n\nBMI ≤ 40 kg/m²'}, 'identificationModule': {'nctId': 'NCT01364233', 'briefTitle': 'Safety Study of MotifMESH (cPTFE) in Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects', 'orgStudyIdInfo': {'id': 'PB-NU-2011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MotifMesh', 'description': 'Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh', 'interventionNames': ['Device: MotifMESH']}], 'interventions': [{'name': 'MotifMESH', 'type': 'DEVICE', 'description': 'Polytetrafluoroethylene (cPTFE) macroporous mesh', 'armGroupLabels': ['MotifMesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Division of Plastic Surgery', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Gregory A Dumanian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}