RECRUITING

GORE® ENFORM Biomaterial Product Study

Conditions

Hernia, Ventral Hernia, Hiatal Hernia, Diaphragmatic Incisional Hernia hernia ventral hiatal diaphragmatic incisional mesh Gore W.L. Gore Enform

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 short-term patient experience.

Official Title

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

Quick Facts

Study Start:2021-05-17

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04718168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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. 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. 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.

Inclusion Criteria

Exclusion Criteria

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.

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.
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.
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.

Contacts and Locations

Study Contact

Shelli Ryczek

CONTACT

928 864 3640

ENF1806@wlgore.com

Principal Investigator

Todd Heniford, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

University of California - San Diego

San Diego, California, 92093

United States

Institute of Esophageal and Reflux Surgery

Denver, Colorado, 80124

United States

Sarasota Memorial HealthCare System

Sarasota, Florida, 34239

United States

Northshore University Health System Research Institute

Evanston, Illinois, 60201

United States

University of Kentucky

Lexington, Kentucky, 40506

United States

Atrium Health

Charlotte, North Carolina, 28204

United States

Prisma Health - Upstate

Greenville, South Carolina, 29615

United States

University of Texas Health Science Center at Houson

Houston, Texas, 77401

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

Todd Heniford, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-17

Study Completion Date2026-09

Study Record Updates

Study Start Date2021-05-17

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

hernia
ventral
hiatal
diaphragmatic
incisional
mesh
Gore
W.L. Gore
Enform

Additional Relevant MeSH Terms

Hernia, Ventral
Hernia, Hiatal
Hernia, Diaphragmatic
Incisional Hernia