GORE® ENFORM Biomaterial Product Study

Not Applicable

Recruiting

• Conditions: Hernia, Hiatal; Hernia, Ventral; Hernia, Diaphragmatic; Incisional Hernia
• Interventions: Device: Gore ENFORM Biomaterial (Preperitoneal); Device: Gore ENFORM Biomaterial (Intraperitoneal)

• Registration Number: NCT04718168
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-22
• Study Start: 2021-05-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

The subject is / has:

1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
5. Willing to provide informed consent and comply with follow-up requirements.

Pre-procedure

Exclusion Criteria

The subject is / has:

1. Treated in another drug or medical device study within 1 year of study enrollment.
2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
3. 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).
4. A BMI >40.
5. Evidence of a systemic infection.
6. Cirrhosis or undergoing dialysis.
7. A wound-healing disorder.
8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
10. A stoma.
11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
12. Positive pregnancy or lactation status as confirmed by site standard of care.
13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.

Post-procedure Inclusion Criteria

At the time of index procedure, the subject is / has:

1. At least 18 years old. Minimum age required by state regulations (as applicable).
2. 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.
3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.

Post-procedure Exclusion Criteria

At the time of index procedure, the subject is / has:

1. Treated in another drug or medical device study within 1 year of study enrollment.
2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
3. 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).
4. A BMI >40.
5. Evidence of a systemic infection.
6. Cirrhosis or undergoing dialysis.
7. A wound-healing disorder.
8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
9. Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
10. A stoma.
11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
12. Positive pregnancy or lactation status as confirmed by site standard of care.
13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial	Gore ENFORM Biomaterial (Preperitoneal)	-
Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial	Gore ENFORM Biomaterial (Intraperitoneal)	-
Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial	Gore ENFORM Biomaterial (Intraperitoneal)	-
Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial	Gore ENFORM Biomaterial (Preperitoneal)	-

Primary Outcome Measures

Name	Time	Method
Hernia Recurrence - Primary Device Endpoint	Through 24 months	Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Incidence of SSOPI - Primary Procedural Endpoint 3	First Post-Procedural Visit (Days 1-45)	Incidence of SSOPI, reported as a composite and individually.
Incidence of SSI - Primary Procedural Endpoint 1	First Post-Procedural Visit (Days 1-45)	Incidence of SSI, reported as a composite and individually.
Incidence of SSO - Primary Procedural Endpoint 2	First Post-Procedural Visit (Days 1-45)	Incidence of SSO, reported as a composite and individually.

Secondary Outcome Measures

Name	Time	Method
Freedom from potential device-related SAEs - Secondary endpoint 1	Through 24 months	Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis.
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3	Through 24 months	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.; Minimum Total Score is 0 and maximum Total Score is 115. Lower score means better outcome.
Relief from GERD Symptoms - Secondary Endpoint 4	Through 24 months	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.; Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0; Heartburn 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.; Regurgitation Score: Calculated by summing the individual scores to questions 10-15.; Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Re-intervention at study-treated location - Secondary Endpoint 2	Through 24 months	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.

Trial Locations

Locations (9)

University of California - San Diego; 🇺🇸 San Diego, California, United States

Institute of Esophageal and Reflux Surgery; 🇺🇸 Denver, Colorado, United States

Prisma Health - Upstate; 🇺🇸 Greenville, South Carolina, United States

Sarasota Memorial HealthCare System; 🇺🇸 Sarasota, Florida, United States

Northshore University Health System Research Institute; 🇺🇸 Evanston, Illinois, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Texas Health Science Center at Houson; 🇺🇸 Houston, Texas, United States