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Recruiting NCT06193551

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

No phase Interventional Paraesophageal Hernia Large Hiatal Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ovitex LPR.
Who it may be relevant to
Registry conditions: Paraesophageal Hernia, Large Hiatal Hernia. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)

Overview

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.

Detailed description

This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair.

Ovitex LPR mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.The biologic material in OviTex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. The permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product.

Preop details, quality of life questionnaires and surgery details will be collected along with post op GERD (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. Data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis.

Interventions

  • Device Ovitex LPR
    Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

Primary outcome measures

  • Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm [Time frame: 5 years]
Secondary outcome measures (1)
  • Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Institute of Esophageal and Reflux Surgery — Lone Tree

Identifiers

NCT: NCT06193551 · TelaBio

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗