[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417629":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":210,"collaborators":11,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":214,"sex":220,"minAge":221,"maxAge":11,"enrollmentInfo":222,"targetDuration":11,"studyType":225,"phases":226,"briefSummary":228,"conditions":229,"keywords":234,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Ventral\u002FIncisional Hernia - Preperitoneal ENFORM Biomaterial","EXPERIMENTAL",null,[13],"Device: Gore ENFORM Biomaterial (Preperitoneal)",{"label":15,"type":10,"description":11,"interventionNames":16},"Ventral\u002FIncisional Hernia - Intraperitoneal ENFORM Biomaterial",[17],"Device: Gore ENFORM Biomaterial (Intraperitoneal)",{"label":19,"type":10,"description":11,"interventionNames":20},"Hiatal\u002FDiaphragmatic Hernia - Preperitoneal ENFORM Biomaterial",[13],{"label":22,"type":10,"description":11,"interventionNames":23},"Hiatal\u002FDiaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial",[17],[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DEVICE","Gore ENFORM Biomaterial (Preperitoneal)","ENFORM Biomaterial bioabsorbable hernia mesh",[19,9],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":11},"Gore ENFORM Biomaterial (Intraperitoneal)",[22,15],[34],{"name":35,"affiliation":36,"role":37},"Todd Heniford, MD","Wake Forest University Health Sciences","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Shelli Ryczek","CONTACT","928 864 3640","ENF1806@wlgore.com",[45,69,82,99,118,139,155,172,193],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of California - San Diego","RECRUITING","San Diego","California","92093","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.16472,32.71571,{"lat":57,"lon":56},[60,64,66],{"name":61,"role":41,"phone":62,"phoneExt":11,"email":63},"Graham J. Spurzem, MD","831-537-8815","gspurzem@health.ucsd.edu",{"name":65,"role":37,"phone":11,"phoneExt":11,"email":11},"Ryan Broderick, MD",{"name":67,"role":68,"phone":11,"phoneExt":11,"email":11},"Hannah Hollandsworth, MD","SUB_INVESTIGATOR",{"facility":70,"status":47,"city":71,"state":72,"zip":73,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Institute of Esophageal and Reflux Surgery","Denver","Colorado","80124",{"type":54,"coordinates":75},[76,77],-104.9847,39.73915,{"lat":77,"lon":76},[80],{"name":81,"role":37,"phone":11,"phoneExt":11,"email":11},"Philip Woodworth, MD",{"facility":83,"status":47,"city":84,"state":85,"zip":86,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Sarasota Memorial HealthCare System","Sarasota","Florida","34239",{"type":54,"coordinates":88},[89,90],-82.53065,27.33643,{"lat":90,"lon":89},[93,97],{"name":94,"role":41,"phone":95,"phoneExt":11,"email":96},"Kristen McKenzie, BSN, RN","941-917-1211","kristen-mckenzie@smh.com",{"name":98,"role":37,"phone":11,"phoneExt":11,"email":11},"Jonathan Yunis, MD",{"facility":100,"status":47,"city":101,"state":102,"zip":103,"country":51,"countryCode":52,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Northshore University Health System Research Institute","Evanston","Illinois","60201",{"type":54,"coordinates":105},[106,107],-87.69006,42.04114,{"lat":107,"lon":106},[110,114,116],{"name":111,"role":41,"phone":112,"phoneExt":11,"email":113},"JoAnn Carbray, CCRP","847-570-3802","jcarbray@northshore.org",{"name":115,"role":37,"phone":11,"phoneExt":11,"email":11},"Michael Ujiki, MD",{"name":117,"role":68,"phone":11,"phoneExt":11,"email":11},"John Linn, MD",{"facility":119,"status":47,"city":120,"state":121,"zip":122,"country":51,"countryCode":52,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"University of Kentucky","Lexington","Kentucky","40506",{"type":54,"coordinates":124},[125,126],-84.47772,37.98869,{"lat":126,"lon":125},[129,133,137],{"name":130,"role":41,"phone":131,"phoneExt":11,"email":132},"Anna Rockich, PharmD","610-212-1086","arockich@uky.edu",{"name":134,"role":41,"phone":135,"phoneExt":11,"email":136},"Sydney Cloyd, RN, BSN","859-218-5151","Sydney.Cloyd@uky.edu",{"name":138,"role":37,"phone":11,"phoneExt":11,"email":11},"John Roth, MD",{"facility":140,"status":47,"city":141,"state":142,"zip":143,"country":51,"countryCode":52,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Atrium Health","Charlotte","North Carolina","28204",{"type":54,"coordinates":145},[146,147],-80.84313,35.22709,{"lat":147,"lon":146},[150,154],{"name":151,"role":41,"phone":152,"phoneExt":11,"email":153},"Greg Scarola, MS","704-355-5766","gregory.scarola@atriumhealth.org",{"name":35,"role":37,"phone":11,"phoneExt":11,"email":11},{"facility":156,"status":47,"city":157,"state":158,"zip":159,"country":51,"countryCode":52,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Prisma Health - Upstate","Greenville","South Carolina","29615",{"type":54,"coordinates":161},[162,163],-82.39401,34.85262,{"lat":163,"lon":162},[166,170],{"name":167,"role":41,"phone":168,"phoneExt":11,"email":169},"Abby Birrell","864-522-2117","abby.birrell@prismahealth.org",{"name":171,"role":37,"phone":11,"phoneExt":11,"email":11},"Jeremy Warren, MD",{"facility":173,"status":47,"city":174,"state":175,"zip":176,"country":51,"countryCode":52,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"University of Texas Health Science Center at Houson","Houston","Texas","77401",{"type":54,"coordinates":178},[179,180],-95.36327,29.76328,{"lat":180,"lon":179},[183,187,191],{"name":184,"role":41,"phone":185,"phoneExt":11,"email":186},"Elaine Tran","713-486-1346","Elaine.Tran@uth.tmc.edu",{"name":188,"role":41,"phone":189,"phoneExt":11,"email":190},"Angilyn R. Rivera","713-486-1350","Angielyn.R.Rivera@uth.tmc.edu",{"name":192,"role":37,"phone":11,"phoneExt":11,"email":11},"Julie Holihan, MD",{"facility":194,"status":47,"city":195,"state":196,"zip":197,"country":51,"countryCode":52,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":54,"coordinates":199},[200,201],-87.90647,43.0389,{"lat":201,"lon":200},[204,208],{"name":205,"role":41,"phone":206,"phoneExt":11,"email":207},"Krissa Packard, MS, ACRP-CP","414-955-1861","kpackard@mcw.edu",{"name":209,"role":37,"phone":11,"phoneExt":11,"email":11},"Matthew Goldblatt, MD",{"type":211,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100417629","gore-enform-biomaterial-product-study-100417629",false,"NCT04718168","GORE® ENFORM Biomaterial Product Study","GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients","ENF 18-06","Pre-procedure Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).\n2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.\n3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.\n4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.\n5. Willing to provide informed consent and comply with follow-up requirements.\n\nPre-procedure Exclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.\n\nPost-procedure Inclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. At least 18 years old. Minimum age required by state regulations (as applicable).\n2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.\n3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.\n\nPost-procedure Exclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Underwent mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.","ALL","18 Years",{"count":223,"type":224},245,"ESTIMATED","INTERVENTIONAL",[227],"NA","A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral \u002F Incisional Hernia Repair and Diaphragmatic \u002F Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.",[230,231,232,233],"Hernia, Ventral","Hernia, Hiatal","Hernia, Diaphragmatic","Incisional Hernia",[235,236,237,238,239,240,241,242,243],"hernia","ventral","hiatal","diaphragmatic","incisional","mesh","Gore","W.L. Gore","Enform","2026-02-17",{"date":246,"type":247},"2026-02-18","ACTUAL",{"date":249,"type":247},"2021-05-17",{"date":251,"type":224},"2026-09",{"name":5,"class":6},9]