Ovitex for Hiatal Hernia

(OviPHeR Trial)

Overseen By Kate Freeman, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foregut Research Foundation

Disqualifiers: Gastric surgery, GERD intervention, Cancer, 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: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Ovitex LPR mesh in repairing large hiatal hernias (where part of the stomach pushes into the chest) or paraesophageal hernias. The researchers seek to determine if using this mesh during surgery enhances the success of repairs. Individuals diagnosed with a large hiatal hernia or a paraesophageal hernia and planning surgery may be suitable candidates for this trial. As an unphased trial, it provides patients the chance to contribute to significant research that could improve surgical outcomes for hernia repairs.

Will I have to stop taking my current medications?

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 Ovitex LPR mesh is safe for hiatal hernia repair?

Research shows that Ovitex LPR, a type of surgical mesh, is generally well-tolerated by individuals undergoing hernia repairs. In earlier studies, patients who underwent hiatal hernia repairs with Ovitex experienced low recurrence rates. Importantly, no complications related to the mesh were reported. Another study found that using Ovitex in surgeries resulted in very few complications, indicating its safety for these procedures. Overall, these findings suggest that Ovitex LPR is both effective and safe for strengthening hernias during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ovitex LPR is unique because it uses a reinforced bioscaffold made from biologically derived materials to support tissue healing during hiatal hernia repairs. Unlike traditional synthetic meshes, which can sometimes lead to complications like erosion or infection, this bioscaffold integrates more naturally with the body’s tissues, potentially reducing these risks. Researchers are excited about Ovitex LPR because it could enhance surgical outcomes by promoting more effective and long-lasting repairs, offering a promising alternative to current synthetic options.

What evidence suggests that Ovitex LPR is effective for hiatal hernia repair?

Research has shown that Ovitex LPR, a special type of reinforced tissue, yields promising results in hernia repair. In a study with 92 patients who underwent ventral hernia repairs using Ovitex, only 2.7% experienced recurrence after 12 months. Other studies have demonstrated that this material offers benefits such as reduced inflammation and improved integration with the body, enhancing healing. Additionally, using Ovitex in abdominal wall reconstruction has significantly lowered the recurrence rate of hernias. These findings suggest that Ovitex could effectively repair large or paraesophageal hiatal hernias. Participants in this trial will undergo surgical repair using Ovitex for their paraesophageal or large hiatal hernias. ^{1 2 5 6 7}

Who Is on the Research Team?

Kate Freeman, MSN

Principal Investigator

Foregut Research Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with large (over 5cm) or paraesophageal hernias. Specific eligibility criteria are not provided, but typically participants would need to be in stable health and meet certain medical guidelines specific to the condition being studied.

Exclusion Criteria

Have a Body Mass Index (BMI) greater than 45

Are pregnant, nursing, or plan to become pregnant

Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Preoperative details and quality of life questionnaires are collected

1-2 weeks

Surgical Treatment

Participants undergo surgical repair of paraesophageal or large hiatal hernia using Ovitex LPR mesh

1 day

1 visit (in-person)

Postoperative Follow-up

Postoperative GERD quality of life questionnaires and barium swallow esophagrams are conducted to examine recurrence

5 years

Multiple visits at 1, 3, and 5 years post-op

What Are the Treatments Tested in This Trial?

Interventions

• Ovitex LPR

Trial Overview The study is testing the effectiveness of a mesh called Ovitex LPR in repairing large or paraesophageal hiatal hernias. The goal is to see if this particular mesh improves outcomes for patients undergoing surgery for these types of hernias.

How Is the Trial Designed?

Group I: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair Experimental Treatment 1 Intervention

This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators.

Ovitex LPR is already approved in United States for the following indications:

Approved in United States as Ovitex LPR 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?

Foregut Research Foundation

Lead Sponsor

Trials

2

Recruited

550+

Published Research Related to This Trial

In a study of 25 patients undergoing hiatal hernia repair, the use of an ovine polymer-reinforced bioscaffold (OPRBS) resulted in excellent symptom control, with 95% of patients experiencing relief from heartburn and 100% from regurgitation and nausea.

There were no clinical recurrences of hiatal hernia reported during the mean follow-up period of 14.2 months, suggesting that OPRBS may be a promising new option for reinforcing hernia repairs, although further studies with larger sample sizes and longer follow-up are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Ovine Polymer-Reinforced Bioscaffold in Hiatal Hernia Repair. Sawyer, MAJ.[2022]

In a study of 62 patients undergoing laparoscopic hiatal hernia repair with porcine urinary bladder matrix (UBM) mesh, the recurrence rate of hernias was 19% at 3 months, indicating that UBM mesh is effective in reducing recurrence compared to unreinforced repairs.

The use of UBM mesh was associated with significant improvements in dysphagia for 75% of patients, and while 56% continued to use proton pump inhibitors post-surgery, the safety profile was strong with no intraoperative complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary Bladder Matrix Reinforcement for Laparoscopic Hiatal Hernia Repair. Zografakis, J., Johnston, G., Haas, J., et al.[2022]

In a study involving 20 female chinchilla rabbits, the composite polypropylene mesh (PP-PG) demonstrated significantly better tissue integration and scar formation compared to standard polypropylene mesh (PP) after 3 months of implantation.

The PP-PG mesh showed higher proliferation rates and a more favorable collagen type I/III ratio in both the esophagus and diaphragm, indicating improved wound healing and remodeling capabilities, which could enhance the effectiveness of surgical treatment for gastroesophageal reflux disease (GERD) and paraesophageal hernia (PEH).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different tissue reaction of oesophagus and diaphragm after mesh hiatoplasty. Results of an animal study. Otto, J., Kämmer, D., Jansen, PL., et al.[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]

In a study of 180 children treated with dextranomer/hyaluronic acid (Dx/HA) for vesicoureteral reflux (VUR), 72% were cured after just one treatment, demonstrating the efficacy of this minimally invasive approach.

The study also found a 4.5% incidence of new contralateral VUR, suggesting that preventive treatment of nonrefluxing ureters may be beneficial, especially as the success rate improved with the experience of the medical team.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of vesicoureteral reflux with endoscopic injection of dextranomer/hyaluronic acid copolymer: the Children's Hospitals of Atlanta experience. Kirsch, AJ., Perez-Brayfield, MR., Scherz, HC.[2016]

In a study of 73 patients undergoing laparoscopic repair of large hiatal hernias with Phasix ST absorbable mesh, the recurrence rate of hernias was low at 3.2%, with no patients requiring reoperation, indicating the safety and effectiveness of this approach.

Patients reported significant improvements in quality of life post-surgery, as measured by both the SF-36 and GERD-HRQL questionnaires, demonstrating the positive impact of the procedure on their health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. Panici Tonucci, T., Asti, E., Sironi, A., et al.[2020]

In a study of 15 patients undergoing laparoscopic hiatal hernia repair with urinary bladder matrix (UBM) reinforcement, all repairs were successful with no recurrences or long-term complications over an average follow-up of 3 years.

The use of UBM showed favorable handling characteristics and resulted in minimal gastroesophageal reflux disease (GERD) symptoms, suggesting it may be a safer alternative to synthetic mesh for reinforcing hiatal hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hiatal Hernia Repair with Novel Biological Graft Reinforcement. Sasse, KC., Warner, DL., Ackerman, E., et al.[2022]

In a study of 54 patients undergoing laparoscopic hiatal hernia repair, the use of acellular human dermis (either FlexHD or AlloDerm) significantly improved GERD symptoms and quality of life without causing mesh-related complications.

The recurrence rates of hernias were similar between the two types of acellular dermis used, indicating that the choice of material does not affect the likelihood of hernia recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acellular human dermis buttress on laparoscopic hiatal hernia repair. Ward, KC., Costello, KP., Baalman, S., et al.[2021]

A new totally absorbable mesh, Gore Bio-A, was successfully used in a laparoscopic hiatal hernia repair for a 65-year-old female patient, showing good handling and adaptability during the procedure without any short-term complications.

While the use of this absorbable mesh may reduce recurrence rates of hiatal hernias, further studies are necessary to assess its long-term effectiveness and safety compared to traditional nonabsorbable options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hiatal hernia repair with gore bio-a tissue reinforcement: our experience. Antonino, A., Giorgio, R., Giuseppe, F., et al.[2021]

In a study involving 60 patients treated for large or complex hiatal hernias, the Phasix™ ST mesh demonstrated no recurrences or mesh-related complications over a median follow-up of 21 months, indicating its safety and efficacy.

The mesh was successfully used in both robotic and laparoscopic procedures without any conversions to open repair or significant postoperative incidents, suggesting it is a reliable option for reinforcing crural defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of large and complicated hiatal hernias with the new resorbable mesh with hydrogel barrier (Phasix™ ST): a preliminary study. Konstantinidis, H., Charisis, C.[2023]

In a study of 85 patients who underwent laparoscopic Nissen fundoplication with MIROMESH Biologic Matrix, significant improvements in quality of life related to gastroesophageal reflux disease were reported post-surgery, along with high patient satisfaction.

The procedure was safe, with only three minor complications that resolved quickly, no mesh-related issues, and no need for further surgeries, indicating a durable repair achieved over a mean follow-up of 1.3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review and Prospective Follow-up of 85 Consecutive Patients Treated With a Novel Hepatic-derived Surgical Mesh for Hiatal Hernia Repair: Outcomes, Surgical Complications, and Revisions. Gillian, GK., Bansal, D.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07070115

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Data collected in this study will be compared to a literature control at 24 months. Official Title. A Prospective Study Evaluating Clinical Hiatal Hernia ...

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

Clinical outcome of OviTex reinforced tissue matrix in ... The results showed better outcomes for RTM in terms of inflammatory response, cellular infiltration, remodeling time, and the formation of new morphologically ...

3. qscience.com qscience.com/content/journals/10.5339/qmj.2025.22

oa Clinical outcome of OviTex reinforced tissue matrix in ... Background: This review provides a comprehensive and current overview of the clinical outcomes associated with the use of OviTex reinforced ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346825003756

The use of a reinforced tissue matrix (OviTex) in paediatric ... Analysis of adult abdominal wall reconstruction using this membrane has demonstrated a significant reduction in hernia recurrence and surgical ...

5. withpower.com withpower.com/trial/phase-paraesophageal-hernia-2024-d47c8

Ovitex for Hiatal Hernia (OviPHeR Trial) 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 ...

6. telabio.com telabio.com/hernia-repair-and-ab-wall-reconstruction/

Hernia Repair & Ab Wall Reconstruction 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. trialx.com trialx.com/clinical-trials/listings/292919/ovitex-in-paraesophageal-and-large-hiatal-hernia-repair/

Ovitex in Paraesophageal and Large Hiatal Hernia Repair The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (>5cm) or paraesophageal hernias when Ovitex LPR mesh used ...