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Mesh

Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair for Paraesophageal Hernia (OviPHeR Trial)

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

OviPHeR Trial 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.Check my eligibility

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.See study design

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.

OviPHeR Trial 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.

OviPHeR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

OviPHeR 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 / 1Eligibility criteria met

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Who is running the clinical trial?

Foregut Research FoundationLead Sponsor

1 Previous Clinical Trials

450 Total Patients Enrolled

Kate Freeman, MSNStudy DirectorForegut Research Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria to be eligible for participation in this research investigation?

"Patients aged 18 to 85 years old who have been diagnosed with paraesophageal hernia are eligible to participate in this trial. The study aims to recruit a total of 150 patients."

Answered by AI

Does this clinical trial include individuals who are above the age of 50?

"To qualify for this clinical trial, individuals must be between the ages of 18 and 85. Notably, there are also separate trials available for patients under the age of 18 (consisting of 18 studies) and patients over the age of 65 (comprising a total of 119 trials)."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Apologies for the confusion. According to the information provided on clinicaltrials.gov, this particular study is not currently seeking participants. It was initially posted on January 1st, 2024 and had its last update on December 20th, 2023. However, it's worth noting that there are currently 151 other ongoing studies actively searching for eligible patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

2024. "Ovitex in Paraesophageal and Large Hiatal Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193551.

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