OviTex Mesh for Hernia Repair

(BRAVOII Trial)

Recruiting at6 trial locations

Overseen by Geoffrey Slayden, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tela Bio Inc

Disqualifiers: BMI > 40, Pregnancy, Drug abuse, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a special mesh called OviTex in patients with ventral or inguinal hernias who are having robotic surgery. The goal is to see if this mesh can lower the risk of complications and prevent the hernia from returning. OviTex is designed to provide better support for the abdominal wall.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment OviTex Reinforced Tissue Matrix for hernia repair?

Research shows that OviTex, a reinforced tissue matrix, is effective in hernia repair by reducing inflammation and supporting the abdominal wall, which helps prevent hernia recurrence. Studies have found that it promotes healing and reduces the foreign body response, leading to better tissue regeneration. ^{1 2 3 4 5}

Is OviTex Mesh safe for use in humans?

Research on OviTex Mesh, used for hernia repair, suggests it may reduce inflammation and support tissue healing, which are positive safety indicators. Studies have shown it can promote healing and reduce foreign body reactions, which are common concerns with surgical meshes. ^{1 2 3 4 5}

How is the OviTex treatment for hernia repair different from other treatments?

OviTex is unique because it combines a biologic scaffold with minimal polymer reinforcement, which helps reduce inflammation and supports the abdominal wall more effectively than traditional polymer meshes. This hybrid design promotes healing by encouraging the body's own cells to integrate with the mesh, potentially reducing the risk of hernia recurrence. ^{1 2 3 4 5}

Research Team

Geoffrey Slayden, MD

Principal Investigator

St. Lukes Hospital

Eligibility Criteria

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.

Inclusion Criteria

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

My wound healing ability is rated as mild to moderate.

My upcoming surgery will be performed using a robot.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic hernia repair using OviTex Reinforced Tissue Matrix

1 day

1 visit (in-person)

Early Follow-up

Participants are monitored for early post-operative complications and surgical site occurrences

3 months

Multiple visits (in-person and virtual)

Late Follow-up

Participants are monitored for late post-operative complications and hernia recurrence

21 months

Visits at 12 and 24 months post-op

Treatment Details

Interventions

• OviTex Reinforced Tissue Matrix (Reinforced Tissue Matrix)

Trial Overview 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.

Participant Groups

Group I: OviTex Reinforced Tissue Matrix Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Tela Bio Inc

Lead Sponsor

Trials

3

Recruited

450+

Emergent Clinical Consulting, LLC

Industry Sponsor

Trials

6

Recruited

2,900+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Findings from Research

In a study using non-human primates, OviTex PRS Permanent and Resorbable matrices showed faster healing outcomes, including earlier host cell infiltration and collagen deposition, compared to AlloDerm, which did not fully integrate into the host tissue.

Both OviTex matrices are less expensive than AlloDerm and demonstrated comparable performance in soft tissue repair, suggesting they may be a more cost-effective option that promotes quicker functional remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Vivo Evaluation of a Reinforced Ovine Biologic for Plastic and Reconstructive Procedures in a Non-human Primate Model of Soft Tissue Repair. Overbeck, N., Beierschmitt, A., May, BC., et al.[2022]

In a study of 92 patients undergoing ventral hernia repair with the reinforced tissue matrix OviTex, only 2.7% experienced hernia recurrence after 12 months, indicating strong efficacy in preventing hernia reoccurrence.

The study reported a 26% rate of surgical site occurrences (SSOs), with 13% of those requiring further intervention, suggesting that while OviTex shows promise, there are still some complications to monitor in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. DeNoto, G., Ceppa, EP., Pacella, SJ., et al.[2021]

In a study involving 25 rabbits, the Phasix™ Mesh showed no detectable abscess or microbial colonization after being inoculated with MRSA, indicating superior safety and efficacy compared to hybrid meshes.

All hybrid meshes tested (Zenapro™, Ovitex™ 1S Permanent, and Ovitex™ 1S Resorbable) exhibited significant microbial colonization and higher abscess scores, highlighting their potential limitations in preventing infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model. Lake, SP., Stoikes, NFN., Badhwar, A., et al.[2022]

The reinforced tissue matrix (RTM) mesh, specifically OviTex, has been shown to effectively prevent the inflammatory foreign body response typically associated with traditional polymer meshes in hernia repairs.

RTM promotes wound healing and supports the regeneration of functional tissue, which helps reinforce the abdominal wall and lower the risk of hernia recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Polymer-Biologic Hybrid Hernia Construct: Review of Data and Early Experiences. Sawyer, M., Ferzoco, S., DeNoto, G.[2021]

Strattice™ Firm demonstrated superior mechanical strength compared to OviTex™ 2S Resorbable, retaining higher maximum load and structural integrity in both in vitro and in vivo tests, indicating it may be more effective for surgical applications.

In animal models, Strattice induced a minimal inflammatory response and integrated well into host tissue, while OviTex 2S-R showed layer separation and higher inflammation, suggesting Strattice may be safer and more effective for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mechanical properties and host tissue response to OviTex™ and Strattice™ surgical meshes. Lombardi, J., Stec, E., Edwards, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

In-Vivo Evaluation of a Reinforced Ovine Biologic for Plastic and Reconstructive Procedures in a Non-human Primate Model of Soft Tissue Repair. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Polymer-Biologic Hybrid Hernia Construct: Review of Data and Early Experiences. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Comparison of mechanical properties and host tissue response to OviTex™ and Strattice™ surgical meshes. [2023]