GORE® ENFORM Biomaterial Product Study (ENF 18-06)

GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Hernia, Hiatal; Hernia, Diaphragmatic; Hernia, Ventral; Incisional Hernia
• Intervention / Treatment: Device: Gore ENFORM Biomaterial (Preperitoneal); Device: Gore ENFORM Biomaterial (Intraperitoneal)

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 Type: Interventional
• Enrollment (Estimated): 245
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shelli Ryczek; Phone Number: 928 864 3640; Email: ENF1806@wlgore.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California - San Diego
      • Contact: Graham J. Spurzem, MD; Phone Number: 831-537-8815; Email: gspurzem@health.ucsd.edu
      • Principal Investigator: Ryan Broderick, MD
      • Sub-Investigator: Hannah Hollandsworth, MD
  • Colorado
    • Denver, Colorado, United States, 80124
      • Recruiting
      • Institute of Esophageal and Reflux Surgery
      • Principal Investigator: Philip Woodworth, MD
  • Florida
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Healthcare System
      • Principal Investigator: Jonathan Yunis, MD
      • Contact: Kristen McKenzie, BSN, RN; Phone Number: 941-917-1211; Email: kristen-mckenzie@smh.com
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University Health System Research Institute
      • Principal Investigator: Michael Ujiki, MD
      • Contact: JoAnn Carbray, CCRP; Phone Number: 847-570-3802; Email: jcarbray@northshore.org
      • Sub-Investigator: John Linn, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University Of Kentucky
      • Contact: Anna Rockich, PharmD; Phone Number: 610-212-1086; Email: arockich@uky.edu
      • Principal Investigator: John Roth, MD
      • Contact: Sydney Cloyd, RN, BSN; Phone Number: 859-218-5151; Email: Sydney.Cloyd@uky.edu
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Atrium Health
      • Principal Investigator: Todd Heniford, MD
      • Contact: Greg Scarola, MS; Phone Number: 704-355-5766; Email: gregory.scarola@atriumhealth.org
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health - Upstate
      • Contact: Abby Birrell; Phone Number: 864-522-2117; Email: abby.birrell@prismahealth.org
      • Principal Investigator: Jeremy Warren, MD
  • Texas
    • Houston, Texas, United States, 77401
      • Recruiting
      • University of Texas Health Science Center at Houson
      • Contact: Elaine Tran; Phone Number: 713-486-1346; Email: Elaine.Tran@uth.tmc.edu
      • Contact: Angilyn R. Rivera; Phone Number: 713-486-1350; Email: Angielyn.R.Rivera@uth.tmc.edu
      • Principal Investigator: Julie Holihan, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Principal Investigator: Matthew Goldblatt, MD
      • Contact: Krissa Packard, MS, ACRP-CP; Phone Number: 414-955-1861; Email: kpackard@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Pre-procedure 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial	Device: Gore ENFORM Biomaterial (Preperitoneal); ENFORM Biomaterial bioabsorbable hernia mesh
Experimental: Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial	Device: Gore ENFORM Biomaterial (Intraperitoneal); ENFORM Biomaterial bioabsorbable hernia mesh
Experimental: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial	Device: Gore ENFORM Biomaterial (Preperitoneal); ENFORM Biomaterial bioabsorbable hernia mesh
Experimental: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial	Device: Gore ENFORM Biomaterial (Intraperitoneal); ENFORM Biomaterial bioabsorbable hernia mesh

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from potential device-related SAEs - Secondary endpoint 1	Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis.	Through 24 months
Re-intervention at study-treated location - Secondary Endpoint 2	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.	Through 24 months
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3	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.	Through 24 months
Relief from GERD Symptoms - Secondary Endpoint 4	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.	Through 24 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Todd Heniford, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Gore; hernia; mesh; ventral; diaphragmatic; hiatal; incisional; W.L. Gore; Enform
• Additional Relevant MeSH Terms: Internal Hernia; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Surgical Wound; Incisional Hernia; Hernia; Hernia, Hiatal; Hernia, Diaphragmatic; Hernia, Ventral; Therapeutics; Drug Administration Routes; Drug Therapy; Infusions, Parenteral
• Other Study ID Numbers: ENF 18-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No