Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-29 @ 12:30 PM
Study NCT ID:
NCT01325792
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2011-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lnorton@wlgore.com', 'phone': '800-437-8181', 'title': 'Lori Norton, PhD', 'organization': 'W. L. Gore & Associates, Inc., Sponsor'}, 'certainAgreement': {'otherDetails': 'Proposed publications/public disclosures within 60 days prior to submission will be provided to sponsor for review by Investigator. Sponsor may make modifications to the proposals only as reasonably necessary to ensure the proper use of any references to itself, its trademarks, and trade names. Sponsor may correct inaccuracies in any technical specifications or descriptions of the biosynthetic material.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'GORE® BIO-A® Tissue Reinforcement', 'description': 'Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.', 'otherNumAtRisk': 104, 'otherNumAffected': 25, 'seriousNumAtRisk': 104, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Surgical site infection', 'notes': 'Secondary outcome event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical site seroma', 'notes': 'Secondary outcome event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bowel obstruction related to concomitant small bowel anastomoses during index surgery', 'notes': 'Secondary outcome event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anastomotic leak related to concomitant bowel resection during index surgery', 'notes': 'Secondary outcome event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hernia Recurrence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-staged Open Complex Ventral Incisional Hernia Repair', 'description': 'primary or recurrent anterior abdominal wall hernia\n\nGORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '26.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at about 24 months', 'description': 'Investigator confirmed hernia recurrence by physical examination', 'unitOfMeasure': '% of subjects with recurrent hernia', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Early and Long-term Complication Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-staged Open Complex Ventral Incisional Hernia Repair', 'description': 'primary or recurrent anterior abdominal wall hernia\n\nGORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after surgery (day 1) to 24 months', 'description': 'Surgical site abdominal wound event rate', 'unitOfMeasure': '% of subjects with events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single-staged Open Complex Ventral Incisional Hernia Repair', 'description': 'GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}], 'recruitmentDetails': '104 subjects recruited from 9 sites in the US and Netherlands between March 2011 and December 2012'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single-staged Open Complex Ventral Incisional Hernia Repair', 'description': 'primary or recurrent anterior abdominal wall hernia\n\nGORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '13.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Wound Classification', 'classes': [{'title': 'Clean-contaminated', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Contaminated', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Intraoperatively assessed, based on the level of contamination present, or due to concomitant surgical procedures, the surgical field was managed to reduce or appropriately eliminate microbial contaminants. After devitalized tissue was removed and the appropriate bioburden reduction techniques completed, the resulting surgical field/wound was characterized and documented as applicable based on the surgical wound classification scheme as suggested by the Centers for Disease Control, US Department of Human Services, with modifications for inclusion of stomas.', 'unitOfMeasure': 'participants'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-18', 'studyFirstSubmitDate': '2011-03-28', 'resultsFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-18', 'studyFirstPostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia Recurrence Rate', 'timeFrame': 'at about 24 months', 'description': 'Investigator confirmed hernia recurrence by physical examination'}], 'secondaryOutcomes': [{'measure': 'Early and Long-term Complication Rates', 'timeFrame': 'after surgery (day 1) to 24 months', 'description': 'Surgical site abdominal wound event rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Complex ventral incisional hernia repair', 'reapproximation of the rectus abdominis muscle', 'retrorectus or intraperitoneal placement technique', 'mobility for midline fascial closure'], 'conditions': ['Ventral Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.', 'detailedDescription': 'The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'general and teaching hospitals', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects will be informed about the study, and will have read; understood and signed the informed consent and authorization to use their PHI, as applicable\n* Subjects willing and able to submit to postoperative follow-up evaluations including quality of life assessments up to 24 months after surgery\n* Subjects of either gender that are at least the age of 18 years\n* Subjects will have a Body-Mass Index (BMI) of \\< 40\n* Subjects will be undergoing single-staged open complex ventral incisional hernia repair with the retrorectus or intraperitoneal placement technique of the GORE® BIO-A® Tissue Reinforcement\n* Subjects in which intraoperatively their surgical field/wound is characterized either a Type 2 or Type 3 in Table 1 in Section 12.0\n* Subjects with a hernia defect \\> 9 cm2 large when measured intraoperatively\n* Subjects in which the required mobility for midline fascial closure without excessive tension to reapproximate the rectus abdominis muscle intraoperatively can be achieved\n* Subjects in which one unit of GORE® BIO-A® Tissue Reinforcement will adequately reinforce the midline fascial closure with at least 4 cm of overlap laterally\n\nExclusion Criteria:\n\n* Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study\n* Subjects with a BMI \\> 40\n* Subjects with evidence of pre-existing systemic infections\n* Subjects with cirrhosis or are currently being treated with dialysis\n* Subjects with a wound-healing disorder\n* Subjects with autoimmune disorder requiring \\> 10mg of a corticosteroid per day\n* Subjects who are immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy\n* Subjects with a hernia defect \\< 9 cm2 large when measured intraoperatively\n* Subjects with a hernia defect requiring more than one unit of GORE® BIO-A® Tissue Reinforcement\n* Subjects in which intraoperatively there is an inability to achieve retrorectus or intraperitoneal placement of the device\n* Subjects in which a midline fascial closure without excessive tension cannot be achieved\n* Subjects in which intraoperatively their surgical field/wound is characterized either a Type 1 or Type 4 in the Table 1 in Section 12\n* Subjects in need of concomitant surgical procedures other than indicated in the protocol as acceptable\n* Subject in which their complex ventral incisional hernia repair requires more than one operation to reduce hernia and close fascia, including serial excision procedures - requiring subsequent surgery to complete their hernia repair\n* Subjects with a hernia repair requiring an emergent procedure, such as strangulated bowel\n* Subjects in which intraoperatively untreated cancer was found"}, 'identificationModule': {'nctId': 'NCT01325792', 'acronym': 'COBRA', 'briefTitle': 'Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement', 'orgStudyIdInfo': {'id': 'CS155'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GORE® BIO-A® Tissue Reinforcement', 'description': 'Single-staged open complex ventral incisional repair of primary or recurrent anterior abdominal wall hernia.', 'interventionNames': ['Device: GORE® BIO-A® Tissue Reinforcement']}], 'interventions': [{'name': 'GORE® BIO-A® Tissue Reinforcement', 'type': 'DEVICE', 'otherNames': ['Biosynthetic Mesh'], 'description': 'Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.', 'armGroupLabels': ['GORE® BIO-A® Tissue Reinforcement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Department of Surgery', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, Case Western Reserve University, Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Nijmegen', 'state': 'The Netherlands', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Michael Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}