BridgeMD
New treatment option for Hernia, Ventral
Official title GORE® ENFORM Biomaterial Product Study
ClinicalTrials.gov ID: NCT04718168
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-procedure The subject is / has:
- At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
- An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
- A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
- An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
You likely can't join if
- The subject is / has:
- Treated in another drug or medical device study within 1 year of study enrollment.
- Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
- Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura...
- A BMI \>40.
- Evidence of a systemic infection.
See the full eligibility criteria
- Pre-procedure The subject is / has:
- At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
- An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
- A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
- An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
- Willing to provide informed consent and comply with follow-up requirements. Pre-procedure
- The subject is / has:
- Treated in another drug or medical device study within 1 year of study enrollment.
- Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
- 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).
- A BMI \>40.
- Evidence of a systemic infection.
- Cirrhosis or undergoing dialysis.
- A wound-healing disorder.
- Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
- Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- 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:
- At least 18 years old. Minimum age required by state regulations (as applicable).
- 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.
- 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...
- Treated in another drug or medical device study within 1 year of study enrollment.
- Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
- 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).
- A BMI \>40.
- Evidence of a systemic infection.
- Cirrhosis or undergoing dialysis.
- A wound-healing disorder.
- Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
- Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Evanston, Illinois, United States
- Lexington, Kentucky, United States
- Charlotte, North Carolina, United States
- Greenville, South Carolina, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Denver, Colorado, United States; Sarasota, Florida, United States; Evanston, Illinois, United States; Lexington, Kentucky, United States; Charlotte, North Carolina, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.