OviTex for Hiatal Hernia

(ECH2O2 Trial)

Recruiting at 1 trial location

Overseen By Danielle Campbell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tela Bio Inc

Disqualifiers: BMI ≥ 35, Nicotine use, Drug abuse, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

133 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called OviTex, a surgical mesh, for individuals needing hiatal hernia repair. The goal is to determine the recurrence rate of hernias and identify any post-surgery complications. All participants will receive the OviTex treatment. Suitable candidates have been advised they require robotic or laparoscopic surgery for their hiatal hernia and do not smoke or have other specific health issues. As an unphased trial, this study provides patients the chance to contribute to important research that could enhance future hernia repair treatments.

Do I have to stop taking 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 study team or your doctor.

What prior data suggests that OviTex is safe for hiatal hernia treatment?

Research shows that OviTex, a type of surgical mesh used to support soft tissue, is generally well-tolerated by patients undergoing hernia repairs. Studies have successfully used OviTex for both large and complex hernias, such as paraesophageal hernias, with good results. Patients experienced successful repairs with few complications.

One study examined hiatal hernias, where part of the stomach pushes through the diaphragm, and found that OviTex strengthened the repair and showed promising results. While ongoing data collection remains important, current findings suggest that OviTex is generally safe for patients, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard mesh implants commonly used for hiatal hernia repair, OviTex Reinforced Tissue Matrix is unique because it combines biologic and synthetic materials. This combination aims to enhance the body's natural healing process while providing the necessary strength and durability to support the repair. Researchers are excited about OviTex because it may reduce the risk of infection and improve integration with the surrounding tissue, potentially leading to better long-term outcomes for patients.

What evidence suggests that OviTex is effective for hiatal hernia?

Research has shown that OviTex holds promise for treating hiatal hernias. Studies have found that OviTex reduces the chances of hernias returning and lowers the risk of complications, such as infections after surgery. It has successfully repaired abdominal walls and hernias, suggesting it could also work well for hiatal hernias. Key benefits include fewer problems at the surgery site and lower rates of hernia recurrence. Overall, OviTex effectively and safely strengthens hernias during surgery. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have a hiatal hernia, which is when part of the stomach bulges through the diaphragm. Details about specific inclusion or exclusion criteria are not provided, so participants should consult with the study organizers to determine eligibility.

Inclusion Criteria

Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.

I am eligible for a specific type of hernia repair surgery using OviTex.

Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.

Exclusion Criteria

Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.

I have a Type I hiatal hernia.

My BMI is 35 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits as per study protocol

Outcome Assessment

Incidence of radiographic recurrence assessed at 24 months

24 months

What Are the Treatments Tested in This Trial?

Interventions

• OviTex

Trial Overview The trial is testing OviTex Reinforced Tissue Matrix products in patients undergoing surgery for hiatal hernia. It aims to see if these products affect the rate at which hernias come back and any complications after surgery.

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.

Who Is Running the Clinical Trial?

Tela Bio Inc

Lead Sponsor

Trials

3

Recruited

450+

Citations

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

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.

2. 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.

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

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

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

The use of a reinforced tissue matrix (OviTex) in paediatric ... Key outcome measures of reconstructive hernia repair are the frequency of surgical site occurrences (SSO) and hernial recurrence.

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

Ovitex for Hiatal Hernia (OviPHeR Trial) Overall, these findings suggest that Ovitex LPR is both effective and safe for strengthening hernias during surgery. Show more.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6305064/

New Ovine Polymer-Reinforced Bioscaffold in Hiatal ... Data collected included demographics, comorbidities and symptoms, details of operation, complications, and postoperative followup. Results: Laparoscopic repair ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06193551/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 ...

8. 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 ...