Recruiting

Ovitex

Sponsor:

Foregut Research Foundation

Code:

NCT06193551

Conditions

Paraesophageal Hernia

Large Hiatal Hernia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ovitex LPR

Study Details

Brief 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

Study ID

NCT06193551

Start date

Feb 19, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair

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.

Interventions

Ovitex LPR

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

Primary outcome measure

  • Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kate Freeman, MSN

3037887700kate@iersurgery.com

Locations

Institute of Esophageal and Reflux Surgery

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Kate Freeman, MSN

303-788-7700kate@iersurgery.com

Rachel Heidrick, BSN

303-788-7700rachel@iersurgery.com

Principal Investigator:

Philip Woodworth, M.D.

More Information

Sponsor

Foregut Research Foundation

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • paraesophageal hiatal hernia
  • paraesphageal hernia
  • hiatal hernia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Foregut Research Foundation on 2026-02-09.