Ovitex in Paraesophageal and Large Hiatal Hernia Repair

NCT06193551 | Recruiting FDA Device

• 1 other identifier: TelaBio
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Large Hiatal Hernia; Paraesophageal Hernia

Keywords

paraesophageal hiatal hernia; paraesphageal hernia; hiatal hernia

Outcome Measures

Primary Outcomes (1)

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

  Assess recurrence rates by objective measures when Ovitex LPR permanent polypropylene polymer reinforcement (Ovitex LPR) is placed during robotic-assisted repair of paraesophageal and large (\> 5cm) hiatal hernias (henceforth PEH) using recurrence rate measurements defined as \> 2cm axial hernia by Barium Swallow or endoscopy, if available

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

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

OTHER

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.

Device: Ovitex LPR

Interventions

Ovitex LPR DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old with PEH and appropriate surgical indication for repair

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foregut Research Foundation: lead

Study Sites (1)

Institute of Esophageal and Reflux Surgery

Lone Tree, Colorado, 80124, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kate Freeman, MSN

  Foregut Research Foundation

  STUDY DIRECTOR

Central Study Contacts

Kate Freeman, MSN

CONTACT

3037887700; kate@iersurgery.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial with a single arm of patients undergoing elective repair of paraesphageal hiatal hernia repair or large hiatal henia repair with implant of Ovitex-LPR.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 5, 2024
• Study Start: February 19, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)