Repairing large hiatal hernias using Ovitex mesh

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Ovitex LPR mesh in repairing large paraesophageal and hiatal hernias. It is a single-site, single-arm investigation focusing on the recurrence rates of hernias and the safety of the mesh. The Ovitex mesh, made from a combination of non-absorbable polymer and absorbable biologic material, aims to enhance tissue remodeling and reduce foreign body response. Data will be collected preoperatively and postoperatively, including quality of life assessments and imaging studies to monitor hernia recurrence over a five-year period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* Under 22 years of age.
* In need of an emergency procedure.
* Currently being treated with another investigational drug or device.
* Have had prior gastric or esophageal surgery.
* Have had any previous intervention for GERD.
* Are suspected or confirmed to have esophageal or gastric cancer.
* Have a Body Mass Index (BMI) greater than 45.
* Cannot understand trial requirements or are unable to comply with follow-up schedule.
* Are pregnant, nursing, or plan to become pregnant.
* Have a mental health disorder that would interfere with your ability to follow study instructions.
* Have suspected or known allergies to Ovitex
* Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.

Where it's running

• Institute of Esophageal and Reflux Surgery
  Lone Tree, Colorado, United States Recruiting

Study contacts

• Study coordinator: Kate Freeman, MSN
• Email: kate@iersurgery.com
• Phone: 3037887700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing mesh and sutures for paraesophageal hernia repair

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• Comparing mesh repair to standard surgery for large hiatal hernias

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• Comparing sutures and polyglactin mesh for hiatal hernia repair

  This study is testing whether using mesh instead of just stitches during surgery can help prevent paraesophageal hernias from coming back in patients.

  Recruiting Oulu University Hospital · Oulu · NCT05201508

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.