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NCT Number: NCT06193551

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

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.

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Key information

Conditions

Paraesophageal Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Large Hiatal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Esophageal and Reflux Surgery

Lone Tree, Colorado, 80124, United States

Location status: Recruiting

Location contact

Kate Freeman, MSN

CONTACT

[email protected]

303-788-7700

Philip Woodworth, M.D.

PRINCIPAL_INVESTIGATOR

Rachel Heidrick, BSN

CONTACT

[email protected]

303-788-7700 ext. 241

Reginald Bell, M.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ovitex LPR

Device

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

Primary outcomes

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

    Time frame: 5 years

    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

Secondary outcomes

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

    Time frame: 5 years

    Assess the safety of using polypropylene support related to potential erosion as assessed by presence of symptoms using study quality of life questionnaire leading to endoscopy demonstrating mesh erosion

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Freeman, MSN

CONTACT

[email protected]

3037887700

Sponsors and collaborators

Lead sponsor

Foregut Research Foundation

Other

Registry information

Official study title

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

Acronym: OviPHeR

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jan 5, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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