Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 7:31 AM
Study NCT ID:
NCT04718168
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GORE® ENFORM Biomaterial Product Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007263', 'term': 'Infusions, Parenteral'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 245}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia Recurrence - Primary Device Endpoint', 'timeFrame': 'Through 24 months', 'description': 'Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).'}, {'measure': 'Incidence of SSI - Primary Procedural Endpoint 1', 'timeFrame': 'First Post-Procedural Visit (Days 1-45)', 'description': 'Incidence of SSI, reported as a composite and individually.'}, {'measure': 'Incidence of SSO - Primary Procedural Endpoint 2', 'timeFrame': 'First Post-Procedural Visit (Days 1-45)', 'description': 'Incidence of SSO, reported as a composite and individually.'}, {'measure': 'Incidence of SSOPI - Primary Procedural Endpoint 3', 'timeFrame': 'First Post-Procedural Visit (Days 1-45)', 'description': 'Incidence of SSOPI, reported as a composite and individually.'}], 'secondaryOutcomes': [{'measure': 'Freedom from potential device-related SAEs - Secondary endpoint 1', 'timeFrame': 'Through 24 months', 'description': 'Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis.'}, {'measure': 'Re-intervention at study-treated location - Secondary Endpoint 2', 'timeFrame': 'Through 24 months', 'description': 'Surgical re-intervention in the area of the hernia repaired initially (e.g. drain insertion, infection, surface issues, second operation, etc.) will be reported descriptively with no formal goals or hypothesis.'}, {'measure': 'Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3', 'timeFrame': 'Through 24 months', 'description': 'For ventral hernia subjects; change in Quality of Life in Carolinas Comfort Scale as measured by a change in total score of the Carolinas Comfort Scale Quality of Life questionnaire given at follow-up visits.\n\nMinimum Total Score is 0 and maximum Total Score is 115. Lower score means better outcome.'}, {'measure': 'Relief from GERD Symptoms - Secondary Endpoint 4', 'timeFrame': 'Through 24 months', 'description': 'For diaphragmatic hernia subjects; relief from GERD symptoms as measured by a decrease in the total score of the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire given at follow-up visits.\n\nTotal Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0\n\nHeartburn Score: Calculated by summing the individual scores to questions 1-6. Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination.\n\nRegurgitation Score: Calculated by summing the individual scores to questions 10-15.\n\nWorst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hernia', 'ventral', 'hiatal', 'diaphragmatic', 'incisional', 'mesh', 'Gore', 'W.L. Gore', 'Enform'], 'conditions': ['Hernia, Ventral', 'Hernia, Hiatal', 'Hernia, Diaphragmatic', 'Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / 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.', 'detailedDescription': 'A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and long-term follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pre-procedure Inclusion Criteria:\n\nThe subject is / 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 / 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 / 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 / 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 / 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 / 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.'}, 'identificationModule': {'nctId': 'NCT04718168', 'acronym': 'ENF 18-06', 'briefTitle': 'GORE® ENFORM Biomaterial Product Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients', 'orgStudyIdInfo': {'id': 'ENF 18-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial', 'interventionNames': ['Device: Gore ENFORM Biomaterial (Preperitoneal)']}, {'type': 'EXPERIMENTAL', 'label': 'Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial', 'interventionNames': ['Device: Gore ENFORM Biomaterial (Intraperitoneal)']}, {'type': 'EXPERIMENTAL', 'label': 'Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial', 'interventionNames': ['Device: Gore ENFORM Biomaterial (Preperitoneal)']}, {'type': 'EXPERIMENTAL', 'label': 'Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial', 'interventionNames': ['Device: Gore ENFORM Biomaterial (Intraperitoneal)']}], 'interventions': [{'name': 'Gore ENFORM Biomaterial (Preperitoneal)', 'type': 'DEVICE', 'description': 'ENFORM Biomaterial bioabsorbable hernia mesh', 'armGroupLabels': ['Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial', 'Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial']}, {'name': 'Gore ENFORM Biomaterial (Intraperitoneal)', 'type': 'DEVICE', 'description': 'ENFORM Biomaterial bioabsorbable hernia mesh', 'armGroupLabels': ['Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial', 'Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Graham J. Spurzem, MD', 'role': 'CONTACT', 'email': 'gspurzem@health.ucsd.edu', 'phone': '831-537-8815'}, {'name': 'Ryan Broderick, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hannah Hollandsworth, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80124', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Philip Woodworth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Esophageal and Reflux Surgery', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristen McKenzie, BSN, RN', 'role': 'CONTACT', 'email': 'kristen-mckenzie@smh.com', 'phone': '941-917-1211'}, {'name': 'Jonathan Yunis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarasota Memorial HealthCare System', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'JoAnn Carbray, CCRP', 'role': 'CONTACT', 'email': 'jcarbray@northshore.org', 'phone': '847-570-3802'}, {'name': 'Michael Ujiki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John Linn, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Northshore University Health System Research Institute', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Rockich, PharmD', 'role': 'CONTACT', 'email': 'arockich@uky.edu', 'phone': '610-212-1086'}, {'name': 'Sydney Cloyd, RN, BSN', 'role': 'CONTACT', 'email': 'Sydney.Cloyd@uky.edu', 'phone': '859-218-5151'}, {'name': 'John Roth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Greg Scarola, MS', 'role': 'CONTACT', 'email': 'gregory.scarola@atriumhealth.org', 'phone': '704-355-5766'}, {'name': 'Todd Heniford, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abby Birrell', 'role': 'CONTACT', 'email': 'abby.birrell@prismahealth.org', 'phone': '864-522-2117'}, {'name': 'Jeremy Warren, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prisma Health - Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77401', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elaine Tran', 'role': 'CONTACT', 'email': 'Elaine.Tran@uth.tmc.edu', 'phone': '713-486-1346'}, {'name': 'Angilyn R. Rivera', 'role': 'CONTACT', 'email': 'Angielyn.R.Rivera@uth.tmc.edu', 'phone': '713-486-1350'}, {'name': 'Julie Holihan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at Houson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Krissa Packard, MS, ACRP-CP', 'role': 'CONTACT', 'email': 'kpackard@mcw.edu', 'phone': '414-955-1861'}, {'name': 'Matthew Goldblatt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Shelli Ryczek', 'role': 'CONTACT', 'email': 'ENF1806@wlgore.com', 'phone': '928 864 3640'}], 'overallOfficials': [{'name': 'Todd Heniford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}