OviTex Mesh for Hernia Repair

(BRAVOII Trial)

Recruiting at 8 trial locations

Overseen By James DeLine, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tela Bio Inc

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 1 day

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests OviTex, a special surgical mesh, to evaluate its effectiveness in repairing ventral or inguinal hernias. Researchers aim to determine if this mesh reduces complications and prevents hernias from recurring after surgery. Suitable candidates for this trial have a hernia requiring surgery and plan to use OviTex in their procedure. Participants should also be willing to answer questions about their quality of life and pain. As an unphased trial, this study provides an opportunity to contribute to valuable research that may enhance surgical outcomes for future patients.

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 prior data suggests that the OviTex Reinforced Tissue Matrix is safe for hernia repair?

Research has shown that OviTex Reinforced Tissue Matrix is generally well-tolerated by patients undergoing hernia repair surgery. One study on ventral hernias found that OviTex performed well, indicating it can be a good option for this type of surgery.

The results are promising, but further research is needed to understand all possible outcomes. So far, reports of serious side effects or complications have been low, suggesting OviTex is relatively safe for patients. However, patients should always consult their healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard hernia repair treatments that primarily use synthetic meshes, OviTex is unique because it's a reinforced tissue matrix combining natural and synthetic materials. This design aims to integrate better with the body’s tissues, potentially reducing complications like infections or rejection common with purely synthetic options. Researchers are excited about OviTex because it might offer a more durable and harmonious repair, improving patient outcomes and recovery times compared to traditional methods.

What evidence suggests that OviTex is effective for hernia repair?

Research has shown that OviTex Reinforced Tissue Matrix holds promise for hernia repair. In one study, only 2.7% of patients experienced hernia recurrence 12 months after surgery. Another study found that improvements persisted even after 24 months. OviTex is designed to strengthen or repair weak soft tissue, reducing the risk of complications. These findings suggest that OviTex could be an effective option for treating ventral or inguinal hernias. ^{1 2 3 6 7}

Who Is on the Research Team?

Geoffrey Slayden, MD

Principal Investigator

St. Lukes Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• OviTex 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.

How Is the Trial Designed?

Group I: OviTex Reinforced Tissue Matrix Experimental Treatment 1 Intervention

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

OviTex Reinforced Tissue Matrix is already approved in United States for the following indications:

Approved in United States as OviTex Reinforced Tissue Matrix for:

• Repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12107482/

Clinical outcome of OviTex reinforced tissue matrix in ... We found that the OviTex RTM shows promising outcomes in reducing recurrence rates, SSOs, SSIs, and postoperative complications. Many types of mesh are used in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40432988/

Clinical outcome of OviTex reinforced tissue matrix in ... OviTex RTM has shown promising outcomes in abdominal wall reconstruction and hernia repair. However, it is crucial to conduct further research and clinical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07070115

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists. What is the study ...

4. ir.telabio.com ir.telabio.com/news-releases/news-release-details/tela-bio-announces-publication-12-month-results-bravo-study

TELA Bio Announces Publication of 12-Month Results from ... A total of 75 patients were evaluated at 12 months, with only two (2.7%) patients demonstrating hernia recurrence adjacent to the original ...

5. researchgate.net researchgate.net/publication/363912376_24-Month_results_of_the_BRAVO_study_A_prospective_multi-center_study_evaluating_the_clinical_outcomes_of_a_ventral_hernia_cohort_treated_with_OviTexR_1S_permanent_reinforced_tissue_matrix

(PDF) 24-Month results of the BRAVO study Continued improvement was observed through 24-months Conclusions Overall the BRAVO study demonstrates that use of the ovine reinforced tissue ...

6. telabio.com telabio.com/tv-inv-overview-referen-090424-tb/

investor overview references OviTex is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias ...

7. ir.telabio.com ir.telabio.com/news-releases/news-release-details/tela-bio-announces-12-month-analysis-bravo-study-ovitexr-ventral

TELA Bio Announces 12-Month Analysis from BRAVO ... "The data from the BRAVO study continues to demonstrate that Ovitex is an excellent choice for the treatment of ventral hernias," said Principal ...