Charlotte, NCNCT04718168Now EnrollingIRB Ready

Hernia, Ventral Clinical Trial in Charlotte, NC

Access cutting-edge hernia, ventral treatment through this clinical trial at a research site in Charlotte. Study-provided care at no cost to qualified participants.

Sponsored by W.L.Gore & Associates

Quick Self-Assessment

See if you qualify for this Charlotte location

Preparing your pre-screening questionsā€¦

Expert Care in Charlotte

Access hernia, ventral specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hernia, ventral treatment provided free

Apply for This Charlotte Location

Check if you qualify for this hernia, ventral clinical trial in Charlotte, NC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Charlotte

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Charlotte site if eligible
  4. 4Begin participation

About This Hernia, Ventral Study in Charlotte

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 GOREĀ® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.

Sponsor: W.L.Gore & Associates

Who Can Participate

Inclusion Criteria

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 GOREĀ® 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

Exclusion Criteria

The subject is / has:
Treated in another drug or medical device study within 1 year of study enrollment.
Implanted with GOREĀ® 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.
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 GOREĀ® 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 is / has:
Treated in another drug or medical device study within 1 year of study enrollment.
Implanted with GOREĀ® 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.
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlotte?

Yes, this clinical trial (NCT04718168) has an active research site in Charlotte, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hernia, Ventral Treatment Options in Charlotte, NC

If you're searching for hernia, ventral treatment options in Charlotte, NC, this clinical trial (NCT04718168) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlotte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hernia, ventral specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hernia, ventral clinical trials near you to find additional studies recruiting in your area.

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