← Back to Search

Mesh

Ovitex for Hiatal Hernia (OviPHeR Trial)

N/A

Recruiting

Research Sponsored by Foregut Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-85 year old with PEH and appropriate surgical indication for repair

Be older than 18 years old

Must not have

Under 22 years of age

In need of an emergency procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is being conducted to see if using a specific type of mesh called Ovitex LPR can improve the success of repairing large hiatal hernias or paraesophageal hernias.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here, but generally, surgical mesh can cause complications like pain, infection, bleeding, reaction to the material, and hernia recurrence. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old and need surgery for my hernia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 22 years old.

Select...

I need an emergency medical procedure.

Select...

I have had treatment for acid reflux before.

Select...

I have had surgery on my stomach or esophagus.

Select...

I am diagnosed with or suspected to have esophageal or stomach cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm

Secondary study objectives

Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repairExperimental Treatment1 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.

0 / 6Eligibility criteria met