Gore ENFORM Biomaterial (Preperitoneal) for Incisional Hernia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Incisional Hernia+3 MoreGore ENFORM Biomaterial (Preperitoneal) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new device to see if it works better than current devices for hernia repair.

Eligible Conditions
  • Incisional Hernia
  • Hiatal Hernia
  • Ventral Hernia
  • Diaphragmatic Hernia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Through 24 months

Day 1
Incidence of SSI - Primary Procedural Endpoint 1
Incidence of SSO - Primary Procedural Endpoint 2
Incidence of SSOPI - Primary Procedural Endpoint 3
Through 24 months
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
Freedom from potential device-related SAEs - Secondary endpoint 1
Hernia Recurrence - Primary Device Endpoint
Re-intervention at study-treated location - Secondary Endpoint 2
Relief from GERD Symptoms - Secondary Endpoint 4

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
1 of 4
Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
1 of 4
Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
1 of 4
Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
1 of 4

Experimental Treatment

245 Total Participants · 4 Treatment Groups

Primary Treatment: Gore ENFORM Biomaterial (Preperitoneal) · No Placebo Group · N/A

Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
Device
Experimental Group · 1 Intervention: Gore ENFORM Biomaterial (Intraperitoneal) · Intervention Types: Device
Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
Device
Experimental Group · 1 Intervention: Gore ENFORM Biomaterial (Intraperitoneal) · Intervention Types: Device
Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
Device
Experimental Group · 1 Intervention: Gore ENFORM Biomaterial (Preperitoneal) · Intervention Types: Device
Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
Device
Experimental Group · 1 Intervention: Gore ENFORM Biomaterial (Preperitoneal) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 24 months

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
87 Previous Clinical Trials
23,704 Total Patients Enrolled
2 Trials studying Incisional Hernia
424 Patients Enrolled for Incisional Hernia
Todd Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
343 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to provide informed consent and comply with follow-up requirements.