Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-10 @ 9:12 PM
Study NCT ID:
NCT02401334
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2015-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Hernia Repair Device Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Surgical Site Infection', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Ventral Hernia', 'Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '32228664', 'type': 'DERIVED', 'citation': 'Minor S, Brown CJ, Rooney PS, Hodde JP, Julien L, Scott TM, Karimuddin AA, Raval MJ, Phang PT. Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix. BMC Surg. 2020 Mar 30;20(1):58. doi: 10.1186/s12893-020-00715-w.'}]}, 'descriptionModule': {'briefSummary': 'This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) \\< 25.\n* Body weight \\< 45 kg\n* Glycosylated Hemoglobin (Hgb A1c) \\> 10%\n* Albumin \\< 2.5 g/dL or pre-albumin \\< 5.0 mg/dL\n* Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) \\< 60 mL/min/1.73 m2\n* Known allergies to study device components\n* Other relevant exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02401334', 'acronym': 'AMEX', 'briefTitle': 'Antimicrobial Hernia Repair Device Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia', 'orgStudyIdInfo': {'id': '13-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hernia Repair', 'description': 'Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.', 'interventionNames': ['Device: Cook® Antimicrobial Hernia Repair Device']}], 'interventions': [{'name': 'Cook® Antimicrobial Hernia Repair Device', 'type': 'DEVICE', 'description': 'Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected', 'armGroupLabels': ['Hernia Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M68HD', 'city': 'Salford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}