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

Trial Summary

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 data supports the effectiveness of the treatment Ovitex for hiatal hernia?

Research shows that using biologically derived mesh, like Ovitex, in hiatal hernia repair can reduce the chance of the hernia coming back. Similar materials have been used successfully in other studies, suggesting that Ovitex might also be effective. ^{1 2 3 4 5}

Is Ovitex safe for use in humans?

The BRAVO study evaluated OviTex for ventral hernia repair and suggested it may reduce inflammation and support the abdominal wall, but specific safety data for hiatal hernia is not available. Other studies on different meshes for hiatal hernia repair reported no mesh-related complications, indicating that similar products can be safe. ^{6 7 8 9 10}

How is the treatment Ovitex LPR different from other treatments for hiatal hernia?

Ovitex LPR is unique because it combines a biologic scaffold with minimal polymer reinforcement, which may reduce inflammation and provide better support compared to traditional synthetic meshes. This approach aims to improve the durability of hernia repair while minimizing complications like mesh erosion and infection. ^{1 2 3 6 11}

What is the purpose of this trial?

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 during the repair.

Research Team

Kate Freeman, MSN

Principal Investigator

Foregut Research Foundation

Eligibility Criteria

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

Have a Body Mass Index (BMI) greater than 45

Are pregnant, nursing, or plan to become pregnant

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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 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 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]

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 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]

References

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

Urinary Bladder Matrix Reinforcement for Laparoscopic Hiatal Hernia Repair. [2022]

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

Effect of acellular human dermis buttress on laparoscopic hiatal hernia repair. [2021]

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

Hiatal hernia repair with gore bio-a tissue reinforcement: our experience. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Different tissue reaction of oesophagus and diaphragm after mesh hiatoplasty. Results of an animal study. [2021]

6. 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]

7. England 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. [2023]

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

Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. [2020]

9. United States 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. [2020]

10. United States 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. [2016]

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

Hiatal Hernia Repair with Novel Biological Graft Reinforcement. [2022]