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Ovitex in Paraesophageal and Large Hiatal Hernia Repair

NCT06193551 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Paraesophageal Hernia
  • Large Hiatal Hernia

Interventions

DEVICE

Ovitex LPR

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

Sponsors & Collaborators

  • Foregut Research Foundation

    lead OTHER

Principal Investigators

  • Kate Freeman, MSN · Foregut Research Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2030-01-31
Completion
2030-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193551 on ClinicalTrials.gov