An interventional study of Ovitex LPR in Paraesophageal Hernia and Large Hiatal Hernia, sponsored by Foregut Research Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Foregut Research Foundation · Not applicable, Interventional, and Treatment
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.
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Foregut Research Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.
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
Time frame: 5 years
Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy
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
Time frame: 5 years
Started Feb 2024 (actual). Primary completion is estimated for Jan 2030, 71 months after the start.
Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's planned 71 months is above that.
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