What side effects are associated with this type of intervention?

The most common treatment for inguinal hernia is surgical repair, often involving the use of mesh for structural support. Known side effects of mesh-based hernia repairs include pain, infection, hernia recurrence, and mesh-related complications such as adhesion, migration, and erosion. Other potential side effects are chronic groin pain and nerve damage. These complications can vary in severity and may require additional medical intervention.

What prior FDA approvals exist?

The FDA has approved various surgical mesh products for the treatment of inguinal hernias, which are designed to provide structural support and reinforce the weakened area. These meshes are typically made from synthetic materials such as polypropylene or biologic materials derived from animal tissues. Products like OviTex, which combine synthetic and biologic materials, aim to enhance tissue integration and reduce complications. The use of surgical mesh has become a standard practice in hernia repair due to its effectiveness in reducing recurrence rates compared to traditional suture methods.

What other types of research exist?

Promising alternatives to OviTex for inguinal hernia patients include Strattice™ (a porcine mesh) and lightweight polypropylene (Ultrapro) mesh, both used in Lichtenstein hernioplasty. Another novel option is the biosynthetic mesh Phasix™, which has shown positive outcomes in hernia repair over a 24-month period.

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Reinforced Tissue Matrix

OviTex Mesh for Hernia Repair (BRAVOII Trial)

N/A

Recruiting

Led By Geoffrey Slayden, MD

Research Sponsored by Tela Bio Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is at least 22 years old, (or considered an adult per state law)

Subject has VHWG score of Grade 1, 2 or 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up occurring > 3 months after index surgery.

Awards & highlights

Summary

This trial will study the safety and effectiveness of a new medical device for treating ventral hernias.

Who is the study for?

This trial is for adults at least 22 years old with a ventral or inguinal hernia that's small enough to be repaired robotically using OviTex mesh. Participants must have a clean to contaminated wound, be able to fill out questionnaires about their quality of life and pain, and commit to the full duration of the study.Check my eligibility

What is being tested?

The study is testing how well OviTex mesh works in repairing ventral or inguinal hernias when used in robotic surgery. It aims to track post-operative complications and chances of the hernia coming back, involving up to 160 subjects across multiple sites.See study design

What are the potential side effects?

While specific side effects are not listed here, common risks associated with surgical mesh may include pain, infection, bleeding, hernia recurrence, adhesion formation (where tissue sticks together), and possible reaction to the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 22 years old or considered an adult by law.

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My wound healing ability is rated as mild to moderate.

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My upcoming surgery will be performed using a robot.

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I need surgery for a hernia in my abdomen or groin area, involving an implant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ occurring > 3 months after index surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~occurring > 3 months after index surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and occurring > 3 months after index surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Early post-operative complications

Early surgical site occurrences or wound related events

Secondary outcome measures

Hernia Recurrence

Late post-operative complications

Late surgical site occurrences or wound related events

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: OviTex Reinforced Tissue MatrixExperimental Treatment1 Intervention

This is a single-arm study. All study subjects will receive OviTex.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for inguinal hernia involves surgical repair, often using a mesh implant for structural support. The mesh acts as a scaffold, reinforcing the weakened area of the abdominal wall and preventing the hernia from recurring. This is achieved by promoting tissue integration and providing a durable barrier that supports the abdominal muscles. For patients, this method is crucial as it reduces the risk of hernia recurrence, minimizes post-operative complications, and typically results in a quicker recovery compared to traditional suture-only repairs.

Antibiotic prophylaxis for hernia repair.